Senior Specialist - Regulatory / Technical Quality

PCI Pharma Services Senior Specialist - Regulatory/Technical Quality in Tredegar, United Kingdom 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 high profile strategic clients with projects through development phase into commercial supply. Main Responsibilities

• Review and approval of technical documents to support manufacture in line with client supplied regulatory approved documentation, ensuring compliance to GMP
• Oversee operational activities supporting the manufacture, packaging and analysis of finished product
• Perform batch review to support QP certification
• Support client and regulatory audits specific to assigned projects
• Provide senior quality insight of strategic client projects
• Main point of quality contact for strategic clients for all quality enquiries
• Attend regular client calls to provide on hand support and advise them
• Support investigations into deviations, out of specification results and requests for change, giving consideration to GMP conformance and compliance to regulatory fillings
  
  Extensive experience working in a quality function in a similar industry
• Experience working within a Regulatory Affairs position
• Degree in a scientific discipline
• Able to adapt in a fast faced manufacturing environment
• Ability to prioritise workload
• Good client management
• Strong presentation and communication skills
  
  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, Diversity, Equity, and Inclusion (DEI) 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. Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

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.