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- Tasks: Ensure compliance and improve quality systems in the pharmaceutical industry.
- Company: Join PCI, a leader in life-changing therapies with a global impact.
- Benefits: Competitive salary, career development, and a chance to make a real difference.
- Why this job: Be part of a team that bridges innovative therapies to patients worldwide.
- Qualifications: Degree in life sciences or related field; experience in regulated industries required.
- Other info: Dynamic role with opportunities for leadership and professional growth.
The predicted salary is between 36000 - 60000 £ 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: Maintain, support and improve the Pharmaceutical Quality System employed within PCI. Oversee the lifecycle management of deviations, including classification, investigation, root cause analysis, impact assessment, and closure. Provide leadership, coaching, and development for the Quality Compliance team. This role is on-site based.
Main Responsibilities:
- Ensure compliance with applicable regulatory requirements (e.g. GMP, GxP), company policies, and quality standards.
- Ensure CAPAs are appropriately defined, risk based, implemented, and verified for effectiveness.
- Maintain oversight of quality metrics (site and global), trends, and recurring issues to drive proactive quality improvements.
- Carry out investigations and investigational cross functional meetings where required.
- Line management responsibility for Quality Officers and/or Quality Administrators.
- 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.
- Support vendor approval and management processes.
- Author standard operating procedures.
- Provide QA and GMP related training.
- Additional duties as required with job level.
Requirements:
- 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.
- 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.
- 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.
Join us and be part of building the bridge between life changing therapies and patients.
Senior QA Officer - Compliance in Bridgend employer: PCI Pharma Services
Contact Detail:
PCI Pharma Services 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 employees at PCI on LinkedIn or through industry events. A friendly chat can give us insider info and maybe even a referral!
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of GMP and GxP regulations. We want to show that we’re not just familiar with the terms, but that we can apply them in real-world scenarios.
✨Tip Number 3
Practice common interview questions related to quality compliance and leadership. We should be ready to share examples of how we've handled deviations or led teams in the past.
✨Tip Number 4
Don’t forget to follow up after the interview! A quick thank you email can keep us fresh in their minds and show our enthusiasm for the role. Plus, it’s a great chance to reiterate why we’re the perfect fit!
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 is tailored to the Senior QA Officer role. Highlight your experience in quality compliance, regulatory requirements, and any relevant projects you've led. We want to see how your background aligns with our mission 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 in the pharmaceutical industry and how you can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Achievements: When detailing your experience, focus on specific achievements that demonstrate your skills in compliance and quality improvement. Numbers speak volumes, so if you’ve improved metrics or led successful audits, let us know!
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’re considered for the role. Plus, it shows you’re keen on joining our team at PCI!
How to prepare for a job interview at PCI Pharma Services
✨Know Your Regulations
Familiarise yourself with the key regulatory requirements like GMP, GxP, and the specific EU/US guidelines mentioned in the job description. Being able to discuss these confidently will show that you understand the compliance landscape and can navigate it effectively.
✨Showcase Your Leadership Skills
Since this role involves line management responsibilities, be prepared to share examples of how you've led teams or projects in the past. Highlight your coaching and development experiences, as well as any successful outcomes from your leadership.
✨Prepare for Technical Questions
Expect questions about your experience with CAPAs, investigations, and quality metrics. Brush up on your technical knowledge and be ready to discuss specific instances where you've implemented improvements or resolved issues in a regulated environment.
✨Demonstrate Your Communication Skills
Strong communication is key in this role, especially when representing the Quality department. Practice articulating your thoughts clearly and concisely, and think of examples where your communication made a positive impact during audits or cross-functional meetings.
