QA ManagerAre you passionate about ensuring the highest standards of quality in pharmaceutical products? Do you thrive in a dynamic environment where innovation and excellence are valued? If so, we have the perfect opportunity for you!As a QA Manager (Commercial), you will play a crucial role in ensuring the quality and compliance of pharmaceutical products throughout their development and commercialization journey. You'll have the chance to collaborate with talented teams, contribute to cutting-edge projects, and make a meaningful impact on patients' lives.Responsibilities and Tasks:Expert Guidance: Provide GMP/GDP quality assurance expertise during the development and commercialization phases.Quality Standards: Ensure all quality activities are initiated and completed according to development stage requirements, maintaining adherence to adequate quality standards.Issue Resolution: Lead the resolution of complaints, testing issues, deviations, discrepancies, and Out of Specifications (OOS), proposing Corrective and Preventive Actions (CAPA) as necessary.Risk Management: Establish a quality risk management approach based on six sigma concepts, ensuring quality is understood and managed throughout the product life cycle.Release Management: Manage activities to support the release of active ingredients, commercial products, and investigational medicinal products, including documentation review and change control assessment.Communication and Collaboration: Notify teams of potential quality, regulatory, and lead time issues, represent quality activities in meetings, and assist in GMP/GDP audits at 3rd party sites.Documentation: Prepare GMP/GDP agreements, write, review, and approve internal SOPs and other GMP/GDP related documentation.System Optimization: Support the review and optimization of the company's pharmaceutical quality system by proposing new procedures or modifications.Required Qualifications and Experience:Educational Background: University degree in Pharmacy, Chemistry, or related technical/science field.Experience: 3-6 years in pharmaceutical product development, quality control, analytical development, or similar operational positions.QA Experience: 3-6 years of experience in quality assurance of drug substance and/or drug product.Industry Knowledge: Understanding of drug substance and/or drug product development, manufacturing processes, quality control, packaging, and distribution.Regulatory Compliance: Good knowledge of (c)GMP/GDP's and ability to interpret and implement quality standards.Project Management: Ability to manage complex projects, prioritize workload, and proactively initiate quality activities.Why Join Us:Impact: Contribute to the development and commercialization of innovative pharmaceutical products that positively impact patients' lives.Collaboration: Work with talented and passionate teams in a dynamic and supportive environment.Growth Opportunities: Expand your skills and advance your career in a global pharmaceutical company committed to excellence.If you're ready to take the next step in your career and make a difference in the world of pharmaceuticals, apply now!
