Quality Specialist

• To provide technical Quality support to the Operational departments for new and ongoing projects.

• Play a lead role in the interpretation of business and regulatory (EU/US/Japan) guidelines which assists with regulatory compliance.

• To promote a sense of quality throughout the site business units so as to raise manufacturing/ development/clinical performance and eliminate waste caused by unnecessary compliance errors.

• To conduct performance audits and follow up on actions within site business units.

• Review and approve, for all areas, Master Batch Records (MBR), master despatch job cards, Technical specifications and addendums, master label approvals, returned Technical Specifications and Technical Agreements. 

• Write and review Drug Product Files (DPFs), Product Specification Files (PSFs) 

• QA approval of Item Masters.

• Batch record compilation and regulatory checks. 

• Interpret PQR data.

• Review and approve Deviations and Change Controls as needed.

• To review non-compliance identified by audit, deviations and complaints, and use technical / professional judgment to make the appropriate product quality decisions (in association with site QP’s), and to initiate and promote quality improvements to prevent re-occurrence.

• To ensure that products proposed for release by a site QP were manufactured in accordance with license requirements, clinical trial application and cGMP.

• To assist with GMP training within the department and cross site.

• The job holder will have significant experience in the pharmaceutical industry, with a diverse knowledge of various dosage form manufacturing and experience of staff supervision. 

• Detailed knowledge of cGMP standards employed at PCI. E.g. EU and US GMP for both drug products and medical devices.

• Experience of working within a Quality Department within a cGMP/pharma environment.

• Previous experience of reviewing and approval of various QA Technical documentation, including but not limited to PSF, DPFs, and Technical Specifications.

• Excellent attention to detail.

• Excellent analytical problem-solving skills and lead by example and get results through persuasion and co-operation.

• Experience of GMP auditing to relevant quality standards with potential to perform audits

• Proficient in Microsoft packages especially Word, Excel and Outlook. 

• Excellent written, listening and verbal communication skillsThe job holder will need to communicate with personnel outside of the Quality group, with external clients, regulatory bodies and consultants. 

• High level of competence in using a QMS/Document Control system. 

Benefits

At PCI, we believe that our employees are our most valuable asset. That's why we are committed to providing a benefits package designed to support your well-being and enhance your overall quality of life. Here's what we offer:

• Employer Pension: Secure your future with our employer pension scheme (above statutory pension).

• Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions.

• Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays.

• Family Friendly Benefits: Enjoy a range of benefits designed to support your family life.

• Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you!

• Staff Engagement: We value your dedication with recognition schemes and long-service awards.

• Health and Well-being: Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary.

• On-Site Subsidized Canteen.

• Cycle to Work Scheme.

• Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.

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