Senior Production Specialist - Hurley, Berkshire
Lucy Stendall at CK Group is recruiting for a Senior Production Specialist to join a company in the Pharmaceutical industry at their site based in Hurley near Maidenhead on a 6 month contract basis.
The Company: Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.In the UK, they have around 2,500 colleagues across five locations, working within their commercial business, research and development (R&D), manufacturing, packaging and distribution operations.
The Location: Located in the countryside close to Maidenhead the Hurley site is home to around 140 employees. Hurley is an office-based site with global and regional teams representing vaccines research & development and customer services, marketing, quality operations, regulatory affairs, medical information and safety.
Responsibilities include to:
- Provide Technical Expertise in issue resolution and impact assessment for aseptically manufactured and terminally sterilized products, relating to production activities such as, but not limited to; deviation impact assessment, assembly, cleaning, processing, full batch review and compliance to module 3 regulatory dossiers.
- Act as the Subject Matter Expert for Production Processes within the Batch Release group, supporting QAOs, QPs, Supply Chain, Above Market Planners, Logistics, Customer Service and Markets.
- Act as a key pillar in the Batch Release On-boarding programme by providing training and coaching to new team members, and to support routine refresher training activities on technical production related matters.
- Support the team with new product launches and impact assess the EU release Quality Management System, create and deliver technical training associated with product specific batch record reviews.
- Liaise with manufacturing and packaging sites to determine level of batch record reviews.
- Provide support to the Quality Assurance (Batch Release) group in order to ensure business requirements and market needs are met, including agreement and supervision of batch release activities.
- Provide support to maintain appropriate compliance oversight for the Batch Release group, including but not limited to: batch document review, support document review/approval, investigation support, review and approval, and support documentation where required.
- Ensure Quality Systems supporting Batch Release are operating effectively and utilised in order to support effective and robust decision making.
To be a successful Senior Production Specialist you should have the following skills, knowledge and experience:
- Degree in science based subject, preferably Biological Sciences, Chemistry, Biochemistry, Pharmacy or Microbiology.
- Experience working in a sterile GXP production environment, minimum of 5 years.
- Direct experience of multi-dose GXP production environment, minimum 5 years.
- cGMP Knowledge.
- Extensive knowledge of cGMP and its implementation by EMEA and FDA authorities.
- Frontline exposure to MHRA/EMEA inspections (FDA would also be an advantage).
- Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced.
- Good understanding where appropriate of analytical techniques utilized in the QC unit.
For more information or to apply for this position, please contact Lucy Stendall on 01246 457733 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 44979 in all correspondence.