Job Description
Piramal Pharma Solutions is a Contract Development and Manufacturing Organisation offering end-to-end development and manufacturing solutions across the drug life cycle. Serving our customers through a globally integrated network of facilities in North America, Europe, and Asia. We research, develop, and supply Biopharma products and services that impact the lives of millions of people each day to make life better, and keep us safer. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovator and generic companies worldwide.
Joining Piramal will give you a chance to build a successful career, impact the lives of millions and enjoy yourself in work. We're proud of the connections we have with our local communities as we work to build a safer future for our country, and we want you to feel that pride when you join us.
At Piramal, interest, ambition and collaboration lead to new challenges, opportunities and a sense of pride in a job well done.
Due to an exciting period of significant growth we are looking to expand our team here at our Morpeth site.
Joining our team as a QA Officer, you will act as a key link between QA and Manufacturing; being the key point of contact for manufacturing for any quality related issues. You will have strong customer relation skills in order to allow you to represent the Quality Department to external clients.
No day is ever the same here at Piramal however, using a collaborative and proactive approach some of your key duties will include:
· Checking components and raw materials purchased and finished products to ensure they meet company specifications. Verifying that products are inspected and tested as required including verifying that imported products (from outside the EU) are tested upon entry.
· Ensuring product is made in accordance with applicable registered details including but not limited to the site Manufacturers Importers Authorisation (MIA) and Marketing Authorisations/ANDA/NDA/IND/IMPD as applicable. Recommending corrective action to ensure conformity with quality specifications and standards if required.
· Releasing materials and bulk drug product for onward internal processing. For clinical trial services: release of primary packed stock for internal secondary packaging/labelling as applicable. Including reviewing finished product batch records prior to QP release to market/trial as applicable.
· Supporting and advising other departments to manage their GMP Commitment Tracking Actions.
· Co-ordinates pre-audit preparation and supports MHRA/FDA and other regulatory body inspections as well as customer audits.
· Liaising with customers and external client in matters pertaining to Quality
To be successful in this role, you will have experience in the pharmaceutical industry in a similar role (QA, QC, Regulatory, etc.) and excellent knowledge of and ability to interpret in a pragmatic, risk-based manner GMP, including the MHRA’s Orange and Green Guides, EU’s Eudralex Vol. 4, USA’s CFR 210 and 211, along with ISO, ICH, GAMP and PIC/S standards.
In addition to a competitive base rate we also offer an extensive range of career development opportunities and industry-leading rewards, incentives and benefits:
- Performance Related Bonus
- Private Medical Insurance
- Health Shield Cash Plan
- Enhanced Holiday Entitlement
- Contributory pension scheme
- National and Local Discounts
- Flexible working opportunities
Piramal is an equal opportunity employer. We are committed to creating an inclusive work environment for all employees and actively encourage applications from all sectors of the community.
Job Types: Full-time, Permanent
Benefits:
- Additional leave
- Company pension
- Cycle to work scheme
- Employee discount
- Flexitime
- Life insurance
- On-site parking
- Private dental insurance
- Private medical insurance
- Referral programme
- Sick pay
Schedule:
Supplemental pay types:
Ability to commute/relocate:
- Morpeth: reliably commute or plan to relocate before starting work (required)
Work Location: One location
Reference ID: QA - Officer Apr23