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- Tasks: Lead quality assurance projects and ensure compliance in a dynamic pharmaceutical environment.
- Company: Join PCI, a global leader in life-changing therapies and innovative solutions.
- Benefits: Competitive salary, inclusive culture, and opportunities for personal and professional growth.
- Why this job: Make a real impact on patient lives while advancing your career in a supportive team.
- Qualifications: Degree in life sciences or related field; experience in regulated industries preferred.
- Other info: Be part of a diverse team committed to equity and inclusion.
The predicted salary is between 36000 - 60000 £ per year.
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
General Purpose of Role:
- Maintain, support and improve the Pharmaceutical Quality System employed within PCI.
- Lead site activities in relation to computer systems validation.
Main Responsibilities:
- Manage and deliver specific validation projects according to business priorities.
- Write, review and approve validation documentation.
- Co-ordinate completion of annual computerised system reviews.
- Technical system Owner/Administrator for the site e-Document Management System and e-Quality Management System.
- Owner of site risk register and maintenance of Quality Risk Management and Data Integrity assessments.
- Line management responsibility for Quality Officers and/or Quality Administrators within the QMS stream.
- Represent the Bridgend Quality department for key client accounts.
- Reporting of metrics for systems within scope of responsibility.
- Support and host client audits of the PCI Bridgend facility.
- Support regulatory inspections of the PCI Bridgend facility.
- Support delivery of site/departmental projects and objectives.
- Support continuous improvement, validation and technical services activities.
- Author standard operating procedures.
- Provide QA and GMP related training.
- Additional duties as required with job level.
Outcomes of Role:
- Maintain validated status of site GxP computerised systems.
- Co-ordinate site CSV projects.
- Maintenance of the compliance of site QMS.
Specific Qualifications:
- HND or degree (or equivalent) in a life sciences, engineering or IT related discipline.
- Experience generating, reviewing protocols, reports or technical documentation within a regulated industry.
Previous Work Experience:
- Good experience in a quality or technical role within a regulated industry (pharmaceutical, clinical, biotechnology or medical device).
- Working knowledge and practical experience with EU/US regulatory requirements (including but not limited to) Eudralex volume 4, Annex 11, Annex 15 and 21 CFR part 11.
- Line management experience would be advantageous.
Specific Knowledge / Skills Competence:
- Good GMP knowledge and experience of EU legislation and guidelines; experience with FDA GMP requirements CFR 210 and 211 other regulatory guidelines preferable.
- Strong communication skills.
- The ability to introduce, co-ordinate, complete and report on projects.
- A high level of self-motivation is required.
- Able to rationally persuade.
- Ability to act as a Subject Matter Expert within area of responsibility.
- Ability to perform audits, internally and externally.
Behavioural Competencies:
- Communication skills – Must be able to communicate at all levels (internally and externally), using different methods and techniques ranging from written reports to formal presentations.
- Interpersonal skills – Able to form and maintain relationships at all levels is essential.
Join us and be part of building the bridge between life changing therapies and patients.
Senior QA Officer - Compliance in Bridgend employer: PCI TRGR Penn Pharmaceutical Services Ltd
Contact Detail:
PCI TRGR Penn Pharmaceutical Services Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior QA Officer - Compliance in Bridgend
✨Tip Number 1
Network like a pro! Reach out to current or former employees at PCI through LinkedIn. A friendly chat can give you insider info and maybe even a referral, which can really boost your chances.
✨Tip Number 2
Prepare for the interview by knowing your stuff! Brush up on EU/US regulatory requirements and be ready to discuss how your experience aligns with PCI's mission. Show them you're not just a fit for the role, but for the company culture too.
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources to get comfortable with common QA officer questions. The more you practice, the more confident you'll feel when it’s showtime.
✨Tip Number 4
Don’t forget to follow up! After your interview, send a thank-you email to express your appreciation for the opportunity. It’s a small gesture that can leave a lasting impression and keep you top of mind.
We think you need these skills to ace Senior QA Officer - Compliance in Bridgend
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your experience in quality assurance and compliance, especially in regulated industries, to show us you're the right fit.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you’re passionate about the role and how your background aligns with our mission. Share specific examples of your achievements in QA and compliance to grab our attention!
Showcase Your Communication Skills: Since strong communication is key for this role, make sure your application is clear and concise. Use professional language but let your personality shine through – we want to see the real you!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from us during the process.
How to prepare for a job interview at PCI TRGR Penn Pharmaceutical Services Ltd
✨Know Your Regulations
Make sure you brush up on EU and US regulatory requirements, especially Eudralex volume 4 and 21 CFR part 11. Being able to discuss these in detail will show that you’re not just familiar with the rules but can apply them practically.
✨Showcase Your Experience
Prepare specific examples from your past roles where you’ve managed validation projects or authored standard operating procedures. This will help demonstrate your hands-on experience and how it aligns with the responsibilities of the Senior QA Officer role.
✨Communicate Effectively
Practice articulating your thoughts clearly and confidently. Since strong communication skills are essential for this position, consider doing mock interviews with a friend or using video tools to refine your delivery.
✨Demonstrate Leadership Skills
If you have line management experience, be ready to discuss your approach to leading teams. Highlight any successful projects you’ve overseen and how you motivated your team to achieve compliance and quality objectives.
