Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Quality Assurance Product Manager – Buckinghamshire

Company: Barrington James Clinical
Location: Marlow
Reference: cs qa
Closing Date: 17 Dec 18
Type: Full Time
Salary (£): 40,000 - 60,000
Benefits:

Job Summary:

We have an exciting opportunity within Buckinghamshire for a Quality Assurance Manager with an exciting, growing Pharma company. To provide QA support for the manufacture of products commercialised within any of the businesses Group of companies. To ensure that each product is manufactured and supplied to the marketplace in compliance with cGMP requirements, Marketing Authorisations, company operating policies and procedures and business requirements.

Requirements:

Why this company:

  • Excellent portfolio covering Oncology / Immunology / CNS / Metabolism / Diabetes
  • New offices / major growth plans
  • Very good culture
  • New launches with Best in Class products coming to market
  •  Excellent package and pension

Key Responsibilities:

  • Participate in the appropriate project management meetings in order to keep abreast of ongoing activities, identifying and addressing any gaps relating to product quality and GMP compliance.
  • Prepare and maintain Technical (Quality) Agreements with third party contractor manufacturing organisations (CMOs) so that roles and responsibilities between the contracted parties are clearly defined and implemented
  • Ensure that an appropriate level of product batch record reviews are carried out at the CMO facilities, as necessary, prior to the release of product for sale and distribution
  • Regularly review non-conformances e.g. process deviations, out of specification/trend results etc at the CMO to ensure that resulting investigations have identified the root cause(s), that suitable reports have been written and that corrective and preventative actions (CAPAs) have been implemented within suitable time periods  
  • Ensure that all changes to GMP documents, processes, equipment and facilities are effectively managed through the CMO and change control processes in order to maintain GMP and regulatory compliance
  • Ensure that GMP stability programmes are established, implemented and regular reports issued by the CMO(s), that trends in data and confirmed out of specification results are investigated and reported, as necessary, to QA management in compliance with cGMP and regulatory requirements
  • For each product, maintain a Product Quality Profile, as registered with the regulatory authorities, and provide to the CMO’s Qualified Person (QP) so that product can be manufactured, controlled and released in compliance with the Marketing Authorisation
  • Participate in the internal audit (self inspection) programme so that any gaps and deviations identified in systems and procedures are addressed by the relevant department and corrective actions followed up within reasonable time scales.

 

 

Experience:

  • A strong understanding of Microbiology
  • A broad experience of working within the pharmaceutical industry of which several years will have been operating in a QA Management position at a sterile products/biologicals manufacturing site.
  • Excellent working knowledge of international GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials

 

Want to find out more, please APPLY now for further details

To find out more about this and other exciting opportunities based in the UK and Europe then please contact Christopher Swain now for an informal and confidential chat about industry possibilities. Please direct all questions (if necessary) to “Chris” at cswain (at) barringtonjames (dot) com alongside a copy of your CV.

Apply for this job: Quality Assurance Product Manager – Buckinghamshire

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.