As the QA Specialist, you will report directly to the Senior QA Specialist and be based at our site in Dudley, Cramlington. The main purpose of your role will be to perform batch sentencing activities on a designated set of products and oversee all quality assurance activities (reviews, approvals, audits, etc.) related to those products and specific plant/business areas. You will maintain quality systems within your areas of expertise, working in accordance with GMP and regulatory standards.
Responsibilities
1. Carry out assigned SAP transactions accurately and promptly as a SAP user.
2. Sentence all controlled intermediates and finished goods within the specified timeframe, following written procedures covering production, analytical review, deviation, and change assessment.
3. Approve PRSs, changes to processes, analytical, and engineering procedures related to specific products to ensure compliance with relevant registrations.
4. Perform QA assessments of 'Decision Paths', non-conformances, and deviations (including out of calibration).
5. Review all cGMP cleanouts and ensure manufacturing does not commence until a satisfactory cleanout is completed.
6. Ensure that specific products and plant/business areas are cGMP compliant through audits, reviews, and monitoring. Identify and close out relevant corrective actions via QATs.
7. Maintain QA systems related to change control.
8. Approve master PRSs and procedures.
9. Handle complaints, audit observations, customer notifications, and coordinate annual reviews.
10. Coordinate validation activities.
11. Comply with all environmental, health, and safety requirements.
12. Embodies company values: be reliable, caring, transparent, and willing.
Qualifications
* Degree or equivalent in a scientific discipline.
* Experience in Active Pharmaceutical Ingredient or Pharmaceutical Industries within quality assurance.
* Comprehensive knowledge of GMP requirements applicable to API manufacturing.
* Experience in API quality assurance, laboratory practices, and production.
* Auditing experience (internal and external).
* Excellent communication skills and experience in writing SOPs and reports.
Why consider Sterling?
Sterling Pharma Solutions is a global CDMO with over 50 years of experience in developing and manufacturing APIs, including ADC research and development. We are a fast-growing, dynamic company with facilities in the UK, US, and Europe, employing over 1300 talented people dedicated to supporting our customers in bringing new medicines to market. Our culture emphasizes delivering an exceptional experience to our customers and employees, fostering a supportive environment focused on science and service.
We offer a competitive compensation and benefits package, including bonuses, pension, private healthcare, engagement initiatives, cycle-to-work schemes, on-site health support, employee assistance programs, referral schemes, social activities, and opportunities for training and career development.
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