Pharmaceutical Validation Specialist
1 week ago
About the Role:
The company Catalent is seeking a highly skilled Pharmaceutical Validation Specialist to join their team. The successful candidate will work on the full scope of Pharmaceutical Validation processes as part of the QA team. This includes equipment, facilities, utilities, and laboratory computer systems validation.
Key Responsibilities:
- Accountable for generating and maintaining the site Validation Master Plan and validating documents such as schedules, plans, protocols, reports, and exceptions, working closely with other functions as necessary.
- Organize and coordinate equipment validations, including new lab instrumentation, operations equipment, and temperature mapping of warehouses.
- Participate in Validation History Reviews for systems to ensure validation practices align with current regulatory requirements.
- Review Process and Analytical Development reports and supporting documentation for new products or product changes, assessing their suitability for validation and reviewing product performance throughout the year, contributing to Product Quality Reviews (PQR/APR).
- Provide technical/validation guidance in assessing process deviations related to equipment performance and impact on product quality.
- Write or amend Batch Manufacturing Records as required when directly related to validation activities for existing products.
- Rigorous risk assessment and management through proactive measures to reduce risks to employees, products, and the environment.
- Manage a Quality Management system at the site, adhering to cGMPs and Catalent standards, covering training, SOPs, internal audits, approval of SOPs, document archiving, site/corporate metrics, supplier management, and validation.
About You:
We are looking for a graduate in Pharmaceutical Sciences or an equivalent professional with experience in leading validation in a cGxP environment, possessing strong knowledge of regulations and legislation related to cGMP. Additionally, you should have experience managing multiple projects, executing validation protocols, and working within a cGMP environment.
What We Offer:
Catalent offers rewarding career opportunities where you can further your skills and advance in the field. As a global leader in drug development and delivery, we collaborate with pharma, biopharma, and consumer health companies worldwide. Our commitment to excellence extends to our people, providing them with challenging roles and opportunities for growth. Join us in making a difference by bringing over 7,000 life-saving and life-enhancing products to patients around the world.
We value diversity, inclusivity, and equal opportunities for all applicants. Catalent is an Equal Opportunity Employer, committed to a culture that respects individual differences and promotes fairness in all aspects of employment. We believe that our diverse workforce is crucial for achieving our goals and creating a positive impact on society.
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