Summary of the QA Specialist role
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, adhering to GMP and regulatory standards.
Your responsibilities
* Carry out assigned SAP transactions accurately and promptly as a SAP user.
* Sentence all controlled intermediates and finished goods within the specified timeframe, following written procedures, including production and analytical review, deviation, and change assessment.
* Approve PRSs and changes (process, analytical, and engineering procedures) related to specific products, ensuring compliance with relevant product registrations.
* Assess all 'Decision Paths', non-conformances, and deviations (including out of calibration) from a QA perspective.
* Review all cGMP cleanouts and ensure manufacturing does not commence until a satisfactory cleanout is completed.
* Ensure cGMP compliance of specific product sets and plant/business areas through audits, reviews, and monitoring, and implement corrective actions via QATs.
* Maintain QA systems related to change control.
* Approve master PRSs and procedures.
* Handle complaints, audit observations, customer notifications, and coordinate annual reviews.
* Coordinate validation activities.
* Comply with all environmental, health, and safety requirements.
* Embody company values: be reliable, caring, transparent, and willing.
Requirements for the role
* Degree or equivalent in a scientific discipline.
* Experience in quality assurance within Active Pharmaceutical Ingredient or Pharmaceutical industries.
* Thorough knowledge of GMP requirements applicable to API manufacturing.
* Experience with API quality assurance, laboratory practices, and production.
* Auditing experience (internal and external).
* Excellent communication skills and proficiency in writing SOPs and reports.
How you will be rewarded
We offer a competitive compensation and benefits package including bonus, pension scheme, private healthcare, Engagement Hub, cycle-to-work scheme, death in service coverage, on-site health and wellbeing support, 24/7 employee assistance, employee referral scheme, sports and social clubs, and opportunities for training and career development.
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 manufacturing. With facilities in the UK, US, and Europe, employing over 1300 talented people, we support our customers in bringing new medicines to market and improving patient lives.
Our culture emphasizes delivering exceptional science and service, fostering a supportive team environment committed to shared goals.
How to apply
If you meet the requirements and wish to join us, please apply online. For queries or support during your application, contact us.
Sterling Pharma Solutions is an equal opportunities employer and encourages applications from all qualified candidates regardless of sex, race, disability, age, sexual orientation, marital status, pregnancy, religion, or belief.
We may close this vacancy early if sufficient applications are received, so early submission is advised.
Be caring. Be transparent. Be willing. Be reliable.
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