Category: Job Adverts

Myonex

Production Quality Manager
Leicester/Hybrid home working (full-time)

Do you have the ability to manage multiple projects, influence stakeholders and nurture a team… all at the same time?

This brand new role will see you managing all GMP labelling related quality activities whilst leading a team and supporting Pharmaceutical Quality System activities. If you are an experienced Quality Manager within clinical trials, please read on!

About Myonex:

For over 30 years, Myonex has been a specialist in global clinical trial supply, with deep expertise in sourcing, management, and labelling of commercial drugs and supplies.

As our reach stretches further around the world, we are looking for a Production Quality Manager to join the Quality team.

The Benefits:

  • Competitive salary
  • Performance-related bonus (up to 15% of your salary)
  • Contributory pension scheme
  • Private medical insurance (after qualifying period)
  • Fast paced, team-oriented environment
  • 29 days’ holiday plus bank holidays
  • Progression and development opportunities

The Role:

This is a varied role with the opportunity to lead on some seriously exciting projects as we continue to grow as a team and business. In a nutshell, you will ensure all GMP labelling activity is completed, adhering to SOPs, including collaborating with department heads to schedule GMP labelling process tasks to meet client requirements.

Leading a small team with a hands-on people management approach, you will encourage development and drive productivity. You will also provide training to all personnel involved in GMDP labelling, be the main contact for our Qualified Person, and you’ll work closely with the Quality Systems Manager.

Other duties will include creating and developing SOPs, performing on-site audits of suppliers, and carrying out both risk management activities, as well as periodic self-inspections.

It’s an exciting time to join us!

About You:

To be our new Production Quality Manager, you’ll need:

  • Pharmaceutical industry experience, from within clinical trials
  • Good knowledge of current relevant EU GMDP regulations
  • People management skills
  • Strong accuracy, organisational and time management skills
  • Great communication and stakeholder management skills

We are a small team, but with big ambitions… so if this sounds like you, we need to talk!

Click here to apply

 

NSF

NSF International

Principal Pharma Biotech Consultant

Competitive Salary + Benefits

Permanent, Full Time

UK or Ireland

 

The expert team at NSF Health Sciences is on a mission to protect and improve human health around the world. We work with leading manufacturers of pharmaceuticals, medical devices, dietary supplements, cosmetics and clinical research throughout the product lifecycle. Our services include training and education, consulting, regulatory guidance, corporate compliance as well as auditing, testing, certification and R&D services. NSF Health Sciences is part of NSF International, a global public health and safety organization focused on the food we eat, the water we drink and the health care products we use. Headquartered in Michigan, USA, with +3000 employees worldwide, NSF offers an exciting opportunity to play a pivotal role in public health at an exception time. Learn more at www.nsf.org

To support, establish, develop, and manage the business interests of NSF Health Sciences we are currently looking for a Principal Pharma Biotech Consultant who will have a particular focus on operation emanating from the UK office.  Expertise including Biotechnology, sterile products and IMP would be an advantage.

In this role you will design, deliver, and maintain a range of bespoke training courses together with the provision of auditing and consultancy services to new and existing NSF Health Sciences Pharma Biotech clients. Whilst managing a team of associates engaged by NSF Health Sciences Pharma Biotech in the delivery of services.

YOUR PROFILE:

  • Bachelor’s degree
  • QP experience within the Pharma industry
  • Ability to interpret and present highly complex and strategically significant information
  • Mastery knowledge of regulations and guidance related to the products within the portfolio of services
  • High level of technical aptitude
  • Previous successful experience within industry or regulators
  • Sounds time management, organisational skills, and attention to detail
  • Excellent communicator, both written and spoken, with great presentation skills
  • Willingness and ability to travel up to 50% of the time

WHAT NSF OFFERS YOU:

If working in an environment that promotes creativity, thought leadership, close collaboration and importantly mitigates risk to human health, then NSF can offer you the chance to make a difference. With its commitment to diversity and gender equality, let NSF help you to build your career aspirations in a multi-cultural setting where everyone’s voice is heard.

Through working alongside highly experienced colleagues, you will learn and develop to become an expert in the provision of state of the art solutions to client needs, by developing and protecting the supply of medicines to patients and end users.

Click here to apply

 

MicroPharm

Qualified Person

MicroPharm is a specialty pharma company which develops and manufactures life-saving medicines for the treatment of snakebite envenomation and poisonings. These products are “Specials” or licensed products.

Job Summary

We are looking for a permanent full time Qualified Person (QP) to join our team, reporting to the Chief Executive Officer. You will participate in all aspects of the management of the Quality Management System with the company’s site licenses (MIA, MIA(IMP), MS and WDA) in use at our sites in Newcastle Emlyn and Cilgerran in Mid-West Wales. The role will also involve certification of parenteral sterile (aseptic) drug product batches.

Key Responsibilities

  • Completes the duties of a Qualified Person on site.
  • Continuous improvement of the QMS ensuring inspection readiness.
  • Support of external and internal Auditing, including regulatory inspections.
  • Qualified Person certification of batches.
  • Management of the Quality System.
  • Management Review preparation.
  • Management of licenses.
  • Regulatory support.
  • Tech Transfer and Clinical Trials.
  • Quality Agreements.
  • Function as a change agent, reviewing and improving established processes.
  • RPI.

Qualifications, knowledge, skills, and experience required

  • Eligible UK Qualified Person with relevant experience within the pharmaceutical industry.
  • Detailed knowledge of current GMP requirements.
  • Demonstrate coaching and mentoring skills.
  • Commercially astute and customer focused.
  • Excellent understanding of the pharmaceutical manufacturing sector in the UK.
  • Excellent project management skills and demonstrates being a completer-finisher.
  • Leadership experience with a strength of character to guide cross functional teams.
  • Can demonstrate analytical and problem – solving abilities.
  • Has a hands-on-approach with an enthusiastic can-do approach.
  • Capable and confident communicator (both verbal and written) at all levels.
  • Well organised with a logical and methodical approach to work.
  • Excellent technical and scientific knowledge.
  • Good Distribution Practice keeping abreast of current legislation, implementation and training of GDP within the company.

Please apply asap. If you have any questions or would like an initial conversation with our Human Resources Manager, Shona Evans, please contact her via email shona.evans@micropharm.co.uk

Applicants must have the right to work in the UK.
Successful candidates will be required to complete a basic disclosure check.

www.micropharm.co.uk

Mawdsleys

 

Qualified Person (QP)

Location: Doncaster, South Yorks

Type: Full time, Permanent

 

Mawdsleys is a global pharmaceutical wholesaler and service provider offering a wide range of services to the pharmaceutical industry and healthcare sector. Our commitment to excellence and high service levels for nearly 200 years has helped us gain a reputation for being a leading partner to the industry and healthcare sector. Working with Mawdsleys, you will get to be part of the team that supplies over 30,000 pharmaceuticals to over 1,000 hospitals annually and we are partnered with manufacturers worldwide to ensure patient access to niche products not readily available in specific territories, come join a company that makes a difference.

Qualified Person (QP)

We are looking for a Qualified Person (QP) to join our team, reporting to the Lead QP. You’ll participate in all aspects of maintenance of the quality systems associated with the company’s manufacturing licenses (MS, MIA and MIA (IMP)) in use at our Quest 22 site in Doncaster. You’ll also undertake routine product and IMP certification as a Qualified Person in accordance with the Human Medicines Regulations Schedule 7 and Annex 16 of Good Manufacturing Practice Part I (Eudralex volume 4).

 Qualified Person (QP) Responsibilities:

  • Assist in maintaining GMP, GDP and GCP standards across all site operations.
  • Assist in the development and approval of new Standard Operating Procedures (SOPs).
  • Assist in the generation and approval of production documentation.
  • Assist in driving the change control process and assist in managing change as required including the provision of training against the needs identified.
  • On a project basis, to lead or assist in the redesign of systems or premises.
  • Take responsibility for specific areas of the quality system as required and agreed with the Lead QP.
  • Assist in the introduction of new client work to site ensuring all processes have been adequately followed. Assist in ongoing maintenance of documentation.
  • Ensure QPulse is being utilised as per Company directives and standards to record and monitor aspects of the QMS.
  • To perform the review and certification as suitable for release for sale batches of product processed at the site.
  • To perform the review and certification as suitable for use batches of clinical trial materials received onto site and those requiring further processing.
  • Maintain familiarity with current industry practice and any changes to national or European legislation.

 Qualified Person (QP) Requirements: 

  • Registered UK/EU Qualified Person with relevant experience within the pharmaceutical industry.
  • Detailed knowledge of current GMP requirements and working knowledge of current GDP requirements.
  • Good understanding of the pharmaceutical manufacturing sector in the UK, EU and third countries.
  • Experience of working with electronic QMS solutions, such as Q-Pulse.
  • Excellent project management skills and demonstrate completer-finisher abilities.
  • Capable and confident communicator (written and verbal) at all levels with first class presentation skills.
  • Commercially astute and customer focused.
  • Demonstrable analytical and problem solving abilities.
  • Have a hands-on approach with an enthusiastic can-do attitude.
  • Demonstrable coaching and mentoring skills.

Click here to apply

Kindeva Drug Delivery

Qualified Person – Quality Assurance

Kindeva Drug Delivery formerly 3M Drug Delivery Systems, Kindeva (pronounced Kin-dev-uh) is fuelled by the same industry experts and offers the same capabilities and technologies, now with unprecedented dedication and flexibility. Our Loughborough site manufactures and packages pharmaceutical and medical products in various forms.

Job Summary

Role reporting into the Quality Assurance Manager and representing Quality Assurance and Qualified Person (QP) duties in the Manufacturing Area (Value Stream). The role will involve batch certification and day to day value stream Quality Assurance support. Site support will also be provided for the Quality Systems and continuous improvement projects related to compliance and training initiatives.

QPs are responsible for undertaking their duties in accordance with a professional Code of Practice. The aims and objectives of the Code of Practice are to provide operational guidelines for carrying out the functions of the QP in accordance with Article 51 of Council Directive 2001/83/EC and Article 12 of Council Directive 2001/20/EC for IMP QP activities.

Major Duties and Responsibilities

  • Completes the duties of a Qualified Person on site for commercial products (pMDIs) in accordance with the details of the Manufacturing Authorisation and Directive 2001/83/EC
  • Completes the duties of a Qualified Person on site for Investigational Medicinal Products in accordance with the details of the IMP Manufacturing Authorisation and Directive 2001/20/EC
  • Attends and contributes to the site critical systems review meeting
  • Reviews and provides input on compliance at the site quality assurance review meeting ensuring systems are in compliance and any actions are documented and progressed accordingly. (Review of Qualification status of relevant equipment and utilities e.g. HVAC, water etc)
  • Actively involved in the Quality Systems Management Review (QSMR) meetings participating in discussions on reviewed information and providing guidance on direction and compliance
  • Completes review of data at Product Quality Review meetings, ensures compliance, approval of documentation and reports. Supports any associated actions with guidance from a Qualified Person and Quality Assurance prospective.
  • Works directly with Regulatory to ensure compliance with current regulations
  • Completes internal and supplier audits as per agreed schedule
  • Approval of deviations, quality incident and stability reports
  • Drives teamwork and completes Continuous Professional Development to ensure compliance with Qualified Person duties
  • Champions active visible leadership for Quality Assurance in order to promote open communication and engagement from the site.
  • Creates a can-do attitude through inspirational coaching and leadership development.
  • Ensure employees uphold Kindeva people policies and ethical behaviours / Kindeva values related to compliance and quality systems
  • Support learning, development and coaching in the value stream relating to compliance and GMP training

Qualifications

  • Eligible to act as a QP (Commercial product essential, IMP preferable)
  • Recently Qualified or experienced QP
  • 3+ years working in the Pharmaceutical Industry

Click here to apply

Please apply asap, if you have any questions email Rebecca.Ellis@Kindevadd.com

www.kindevadd.com

 

 

Custom Pharma

Quality Manager – QP

Brighton & Hove, East Sussex

Competitive salary and benefits package

We are looking for a permanent, full-time Qualified Person.

Company Description

About Custom

Custom Pharma Services is an established contract development and manufacturing organisation with a broad portfolio of commercial and development products. We have a proven track record of designing and developing new oral solid dose formulations, supporting our clients from formulation development to clinical then to commercial scale manufacturing and packaging.

Custom is a great place to work where teamwork and support is encouraged, where every individual is valued and supported to achieve their full potential because if you can, then Custom Can! 

This is an exciting time to join us as we embark on a major project to complete the build of our new manufacturing facility in Brighton & Hove.

Key responsibilities are:

  • QP certification of IMPs and marketed products
  • Continuous improvement of the QMS ensuring inspection readiness
  • Support, review and approval of investigations, deviations, change proposals and product quality complaints
  • Drive improvement initiatives based on review of quality system metrics
  • Act as a change agent, reviewing and improving established processes
  • Maintain effective communication with internal and external clients
  • Support of regulatory and client audits
  • Coaching and developing the team in line with the Company’s policy of being an ‘Investor in People’

About You

Qualifications, knowledge, skills & experience required:

  • Eligible to act as a QP in the UK (Commercial and IMP)
  • Demonstrated experience as a releasing QP (ideally oral solid dosage)
  • Excellent scientific and technical knowledge
  • Excellent knowledge of the principles and guidelines for GMP and GDP as per: UK Orange Guide, Eudralex Volume 4, US CFR’s and other relevant regulations.
  • Well organised with a logical and methodical approach to work.
  • Excellent written and verbal communication skills.
  • Leadership experience with strength of character to guide cross-functional teams of professionals.

Benefits package includes:

Hybrid working on completion of probation period; Individual bonus payment based on successful performance; Pension; Life Assurance; Health Plan and Subsidised Gym Membership

Relocation support offered to candidates not based within commutable distance

Click here to apply

If you have any questions or would like an initial conversation with our Recruitment Manager, Jane Austen, please contact her via email: Jane.Austen@custompharma.co.uk

Applicants must have the right to work in the UK.

Successful candidates will be required to complete a basic disclosure check.

www.custompharma.co.uk