Category: Job Adverts

Mawdsley

 

Qualified Person (QP)

We are looking for a Qualified Person (QP) to join our team, reporting to the Lead QP. Ideally, you will be a registered EU Qualified Person with relevant experience in the pharmaceutical industry, but we are also interested to hear from anyone who is working towards this and looking for an employer to support them through the final stages of accreditation.

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 article 51 of 2001/83/EC 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 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.

 About Mawdsleys:

Mawdsleys are a global pharmaceutical service provider offering a wide range of services to the pharmaceutical industry and healthcare sector. We are the largest independent pharmaceutical wholesaler in the UK with a fast growing international network supplying medicines to meet patient needs and providing a route to market for manufacturers. We are fully managed and regulatory compliant sourcing imported medicines for specific patient needs.

Location: Doncaster, South Yorks

Type: Full time, Permanent

Salary: Up to £70,000 per annum dependent on experience

Click here to apply

NSF 18/03/2021

NSF International

Executive Director, Pharma Biotech Consulting

Internal title: Senior 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 an Executive Director, Pharma Biotech Consulting, who will have a particular focus on operations emanating from the UK office.

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 with QP experience within the Pharma industry
  • Expertise including Biotechnology, sterile products and IMP would be an advantage
  • 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
  • Documented successful experience within industry or regulators
  • 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