Assure product quality by developing, implementing, and maintaining QA systems for PHARMA API and specialty chemicals production.
**Key Responsibilities:**
- Develop, review, and enforce QA procedures and documentation (batch records, test methods, COAs).
- Conduct audits of production and laboratory processes to ensure adherence to quality standards.
- Investigate product complaints and non-conformities, implementing CAPA (Corrective Actions / Preventive Actions).
- Coordinate with production and R&D; for new product introductions and process validations.
- Ensure compliance with REACH, ISO, and Customer-specific requirements.
**Requirements:**
- M.Sc/B.Sc in Chemistry or equivalent background.
- 7+ years’ QA experience in PHARMA API and specialty chemicals production.
- Excellent knowledge of analytical techniques, QA principles, and regulatory compliance.
- Strong communication, documentation, and problem-solving abilities.
Prepares quality documentation and reports by collecting, analyzing, and summarizing information and trends.
- Creates and implements company quality standards.
- Accomplishes quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures.
- Trains and motivates employees to ensure that quality standards are met.
- Achieves quality assurance operational objectives by contributing to information analysis.
- Meets financial objectives by estimating requirements, preparing annual budgets, and scheduling expenditures.
- Develops quality assurance plans by conducting hazard analyses and monitoring procedures.
- Validates quality processes by establishing product specifications and quality attributes.
- Assists in the recruiting process.
- Maintains and improves product quality by completing product, company, system, and compliance audits.
Quality Assurance Manager Qualifications and Skills
- Excellent data analyzing and review skills
- Robust technical and computer skill