At a Glance
- Tasks: Ensure quality assurance for life-changing therapies and support regulatory compliance.
- Company: Join PCI, a leader in biopharma with a global impact.
- Benefits: Competitive salary, inclusive culture, and opportunities for career growth.
- Other info: Dynamic environment focused on continuous improvement and teamwork.
- Why this job: Make a real difference in patients' lives through quality assurance.
- Qualifications: 2+ years in a regulated quality role and a life sciences qualification.
The predicted salary is between 30000 - 40000 £ per year.
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.
General Purpose of Role: To perform a Quality Assurance role which supports:
- Certification and release of medicinal products in accordance with regulatory, company and project requirements.
- Maintain, support and improve the Pharmaceutical Quality System employed within PCI.
Main Responsibilities:
- Support the QP in execution of their legal and operational duties.
- Administration, control and support core systems within the Pharmaceutical Quality system as allocated by line manager. Including but not limited to Internal audits, vendor management, deviations/complaints, CAPA, change control and document control.
- Reporting of metrics for systems within scope of responsibility.
- Support and host client audits 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.
Outcomes of Role:
- Schedule, host and close out client audits.
- Pre-certification assessment of batch records and generation of draft QP certificates.
- Post QP certification batch release via the inventory system.
- Review and approval of offsite shelf life extension labelling activities.
- Pre-approval assessment of change controls and deviations.
- Co-ordinate and perform investigations into internal and external quality issues.
- Assess temperature excursions during shipment in line with the stability profile of the product(s).
- Approval of completed investigations, CAPA’s and change controls.
- Schedule, perform and close out internal and external audits within established timelines.
- Pre review of validation/qualification protocols.
Previous Work Experience:
- Minimum two years experience in a Quality role within a regulated industry (pharmaceutical, clinical, biotechnology or medical device).
- Experience within a regulated industry (pharmaceutical, clinical, biotechnology or medical device).
- Holds a qualification in a life sciences subject (HNC, HND or degree or equivalent) in a life sciences subject or suitable experience in a Quality Assurance or technical role within the pharmaceutical industry.
- 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.
- Quality Officers need to be familiar with standard computer applications currently in use by the company.
- Interpersonal skills: able to form and maintain relationships at all levels is essential. A Quality Officer must be able to effectively convey potential quality issues and offer constructive advice when required.
- Thinking and decision making: a Quality Officer will often need to make decisions and advise on appropriate courses of action in the event of a Quality incident or to agree appropriate Corrective and Preventative actions. A Quality Officer should be able to consider all relevant aspects and possible repercussions regarding these quality issues.
Join us and be part of building the bridge between life changing therapies and patients.
QA Officer in Bridgend employer: PCI TRGR Penn Pharmaceutical Services Ltd
At PCI, we are dedicated to fostering a culture of inclusivity and growth, making us an exceptional employer for those seeking to make a meaningful impact in the pharmaceutical industry. Our Bridgend facility offers a collaborative environment where employees can thrive through continuous learning opportunities, competitive rewards, and a commitment to quality and operational excellence. Join us in bridging life-changing therapies to patients while advancing your career in a supportive and dynamic workplace.
Contact Details:
PCI TRGR Penn Pharmaceutical Services Ltd Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land QA Officer in Bridgend
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching PCI and understanding their values and mission. Tailor your answers to show how your experience aligns with their goals, especially in quality assurance and compliance.
✨Tip Number 3
Practice common interview questions related to quality assurance. Think about scenarios where you've handled audits, CAPAs, or deviations, and be ready to discuss them in detail.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're genuinely interested in joining the PCI team.
We think you need these skills to ace QA Officer in Bridgend
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the QA Officer role. Highlight your relevant experience in quality assurance and any specific skills that match the job description. We want to see how you can make an impact at PCI!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how your background aligns with our mission at PCI. Let us know what drives you to apply for this role.
Showcase Your Achievements:Don’t just list your responsibilities; showcase your achievements in previous roles. Whether it’s successful audits or improvements in quality systems, we love to see how you've made a difference in your past positions.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at PCI TRGR Penn Pharmaceutical Services Ltd
✨Know Your Quality Assurance Basics
Make sure you brush up on your knowledge of GMP and EU regulations, as well as FDA guidelines. Being able to discuss these confidently will show that you understand the core responsibilities of a QA Officer.
✨Prepare for Scenario Questions
Expect questions about how you would handle specific quality incidents or deviations. Think of examples from your past experience where you successfully managed similar situations, and be ready to explain your thought process.
✨Showcase Your Communication Skills
As a QA Officer, you'll need to convey complex information clearly. Practice explaining technical concepts in simple terms, and be prepared to discuss how you've effectively communicated with different teams in previous roles.
✨Demonstrate Your Problem-Solving Abilities
Be ready to discuss how you've introduced improvements or solved quality issues in the past. Highlight your ability to rationally persuade others and coordinate projects, as these skills are crucial for the role.
