Job Adverts

Ref: 20120503-1W

Quality Manager – QP, Leamington Spa, Warwickshire.

Up to £60k + Bonus + Benefits + Relocation

Based at our EMEA Headquarters in Leamington Spa, Hospira have an opportunity available for a Quality Manager – QP.

This is a key role for the business with where your key responsibilities include:

  • Batch Release
  • SOPs
  • Documentation and Certification
  • Training
  • Health and Safety

To be considered for this opportunity you will have substantial experience on a site holding a current Manufacturers License or Manufacturers Import Authorisation and have worked within a manufacturing and packaging environment. Sterile manufacturing experience is preferred. Knowledge of SAP is essential, as is management experience. You will have a Degree in Pharmacy, Chemistry, Biology, or relevant discipline, and be suitable to be nominated as a Qualified Person as satisfying Articles 49 & 50 of EU Directive 2001/83/EC and the amended 2004/27/EC, along with current listing on Indicative Register for Human Medicinal Products.

This is a great opportunity for an experienced QP looking to progress their career and in return you will be rewarded with a competitive remuneration package.

Applications should be sent in the first instance to lisa.mcgill@monster.co.uk

 

Ref: 20120312-1W

QUALIFIED PERSON (QP)

Fixed term 12 months

Ernest Jackson is a company with almost 200 years experience and expertise in developing, manufacturing and marketing medicated confectionery and vitamin supplement products. Ernest Jackson offers a wide range of well known branded products as well as a one-stop contract manufacturing service, and has become one of the UK’s leading medicated confectionery manufacturers. As a subsidiary of Kraft Foods (the second largest food manufacturer in the world) a role at EJ offers the flexibility and autonomy of a SME with the backing and opportunity of a Global business.  EJ are looking for a Qualified Person to support the supply chain team in delivering effective, sustainable GMP improvement.

Key Accountabilities

  1. To perform routine QP duties and batch certification in accordance with EU directive 2001/83/EC and the code of practice
  2. To provide support and direction to the Quality function regarding
  • Current and future legal requirements
  • Defining the quality agenda
  • Embedding and driving improvement to the change control process
  • Specification and licence compliance
  • Maintaining the interface with regulatory bodies and third party consultants

3. To provide clear, timely communication of product disposition (release/hold/reject)

4. To coach and support the development of a trainee QP

Pre-requisites

In order to succeed in this role, it is expected that you will have:

  • Qualified Person status
  • Several years experience as a QP within a change and improvement orientated Pharmaceutical Company
  • Commercial acumen
  • Experience of hosting FDA/MHRA/ISO and other external audits
  • Ability to work under pressure with a changing environment and maintain strict deadlines, prioritising workload effectively
  • Excellent influencing skills at all levels

Interested Applicants

Please send curriculum vitae and covering letter to Robert Frater, Head of Quality
by 30th March 2012.

 
Ref: 20111220-1W 


 

QC Laboratory Manager

A QC Laboratory Manager is required to lead and manage a team of 7 analysts in a small but fast-growing pharmaceutical company based in the South East of England. 

The QC Department supports the Production departments, stability studies, and provides additional support for the Development departments and quality investigations. 

Ideal candidates will have a BSc in Chemistry (or equivalent) and have experience in managing or supervising an analytical laboratory in a GMP environment encompassing Pharmacopoeial and in-house testing. Experience in stability, method validation and troubleshooting for various analytical techniques such as HPLC, GC, IR, and UV is essential. Empower experience would be beneficial. 

The laboratory is responsible for the analysis of pharmaceutical raw materials, active ingredients, and finished products to ensure that they comply with internal and regulatory specifications. Chemical analysis, stability testing, protocol writing, and checking analytical data in accordance with cGMP are all within the scope of the role. 

Key duties and responsibilities will include: 

  • Providing leadership and management within the department through a structural process of objective setting, performance appraisal, and individual development.
  • Improving the overall department productivity and efficiency
  • Ensuring all QC operations are carried out in accordance to cGMP
  • Reviewing and approving analytical data & results, ensuring that they comply with internal and regulatory specifications
  • Ensuring robust training and self-inspection programs within the laboratories, as well as the review of SOPs, investigations, specifications, methods, validation reports, and cleaning verification reports
  • Implementing new procedures
  • Maintain the risk-based and scientific-based quality system as part of the Quality Unit
  • Establishing and maintaining efficient workflows to ensure operational excellence
  • Facilitation of method transfers

Applications from Qualified Persons are welcomed in order to provide on-site coverage to the main company QP. 

All applications to be received by Friday 13th January 2012. 

To apply please send your CV and covering letter to: 

Crissy Clark
GW Pharma Ltd
Building 114
Porton Down Science Park
Salisbury
Wiltshire
SP4 0JQ 

or by email to: ca@gwpharm.com 

Ref: 20111212-1W



 

Pharmaceutical GMP and QP Tutors

RSSL is a specialist scientific organisation based on campus at the University of Reading, offering training, consultancy, analysis and research. 

For over a decade, delegates have praised our well respected training programmes in GMP. Earning similar praise, our modular Qualified Person course has an outstanding record of success for those who go on to take the viva. Delegates favour our informal, practical and focused approach to the subject matter. 

Courses are run at our dedicated training facility in Reading, or ‘in-house’ at a client site, when they can be tailored to a company’s own requirements. 

We are now seeking additional tutors to support our business, so that our delegates can continue to benefit from the pragmatic and in-depth knowledge that experienced professionals are able to bring. 

We are looking for professionals who are experienced in GMP and Qualified Person activities, with the enthusiasm and personality to enhance our team. Applications will be particularly welcomed from present or former QP assessors who are able to make the commitment to our programme. 

For an informal chat about the course programme and what being a tutor for RSSL means to you, call Lyndsey Wright [Head of RSSL Training] on 0118 918 4165. 

To see the range of courses and more information about RSSL training visit our website at: 

http://www.rssl.com/services/pharmaceuticalandhealthcare/training/Pages/training.aspx 

To apply please send a current copy of your CV or request for an application form to Lyndsey.wright@rssl.com 

 Ref: 20111208-1W



 

QA Pharmacist

Greater Manchester, Bolton area

Full time Salary £36,000 to £38,000 per annum

Part of a long established and reputable company in the pharmacy industry, Middlebrook Laboratories is an exciting new venture. Continually developing new initiatives to better serve patients and maintain our reputation for delivering excellence, we are now introducing a brand new purpose built Specials Production Facility to manufacture and supply specials products to pharmacies, with a view to achieving rapid expansion. 

We can therefore offer a fantastic opportunity for you to be involved in this thrilling project. 

Job purpose: 

  • Work within the Quality Management systems at Middlebrook Laboratories to maximise quality and efficiency and ensure compliance with current regulations for all medicinal products managed by the facility.

Key Responsibilities 

  • Release of finished products manufactured in the Clean room
  • Approval of raw materials and wholesale specials or special obtains handled by the unit
  • Reporting and recording fails, reworks and other non-compliance
  • Operate CAPA system, recording out of specification and deviation events, etc
  • Managing documentation system
  • Coordinate, write, manage to resolve customer complaints, recalls, change controls, ensuring proper root cause analysis, prompt responses/ resolution
  • Generate or assist in the generation or review of SOPs.
  • Dealing with suppliers regarding quality enquiries for raw materials
  • Validating equipment
  • Providing technical expertise to the customers
  • Utilise scientific sources in order to work on improving quality of products and services
  • Generate supplier audit documentation and technical agreements, and help in preparation of external audits.
  • Participate in the internal audit programme to ensure continued cGMP compliance of all site activities.
  • Generate, assist in the generation or review of other technical documents, raw materials specifications, qualification documentation, validation documentation
  • Sampling Raw materials
  • Liaise with suppliers in order to obtain documents needed for internal Quality Approval
  • Advise and assist manufacturing staff when requested to do so.
  • Plan and carry out research projects appointed by the Quality Manager
  • Interact with customer services in order to improve operations and quality of services
  • Keep up to date with changing regulations.
  • Collate data on aspects of the quality management system for incorporation into regular periodic reports.
  • Participate in quality improvement initiatives.

Requirements 

  • GPhC Registered
  • Minimum 2 years post register experience
  • Previous experience of working in a Quality field is essential.
  • Experience of working in a GMP environment in the pharmaceutical industry involving specials products is preferable.

Competencies  

  • Experience of operating within a Quality Management Systems
  • Able to write SOPs
  • Oversight of Quality Management Systems
  • Strong IT system application skills 

If you are tempted by this opportunity, please email your CV to Joanna Kurek