Quality Specialist - Technical en PCI Pharma Services
PCI Pharma Services · Tredegar, Reino Unido · Onsite
- Professional
- Oficina en Tredegar
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Main purpose of the role
To support the review, approval, and maintenance of technical documentation across Commercial, Clinical, and high-potent (CMF/DCF) areas for the QA group.
Responsibilities
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.
Requirements
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 skills The 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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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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