Bayer is a global leader in life sciences, focusing on pharmaceuticals, consumer health, and crop science. The company is committed to creating a world where “Health for all, Hunger for none” is a reality. Bayer fosters innovation, collaboration, and professional growth, making it an ideal workplace for passionate individuals. With a strong emphasis on quality assurance and regulatory compliance, Bayer offers a dynamic work environment that encourages continuous learning and career advancement.
Responsibilities in Job
The GMP – QA Documentation role at Bayer entails key responsibilities such as:
- Documentation Management: Preparing and reviewing Standard Operating Procedures (SOPs), Specifications, Method of Analysis, Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), Master Formula, and other key forms.
- Production Monitoring: Ensuring compliance with Good Manufacturing Practices (GMP) by monitoring in-process controls and critical production activities.
- Audit and Compliance: Ensuring internal and external audit readiness and addressing audit observations.
- Quality Management Systems (QMS): Handling Change Control, Deviation Management, Corrective and Preventive Actions (CAPA), and Incidences.
- Batch Release: Reviewing all necessary documentation related to the release of Active Pharmaceutical Ingredients (APIs).
- Complaint Handling: Managing customer complaints, product recalls, and returned products.
- Training and Vendor Management: Overseeing training programs and coordinating with external vendors and service providers.
- Validation and Qualification: Reviewing validation and qualification activities to maintain regulatory compliance.
Qualifications
To be eligible for the GMP – QA Documentation role at Bayer, candidates must have:
- A B. Pharm, M. Pharm, or M.Sc. degree.
- A minimum of 3-4 years of experience in the Quality Assurance (QA) department within the pharmaceutical industry.
Skills Required
Candidates must possess the following key skills:
- Strong knowledge of GMP and regulatory compliance.
- Expertise in document preparation and review.
- Familiarity with Quality Management Systems (QMS).
- Experience in handling audits, deviations, and CAPA.
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork abilities.
Work Relations
The role involves collaboration with various internal and external stakeholders:
Internal Departments:
- Engineering (Utility, Maintenance, Project Services, PCT)
- Quality Control
- Warehouse
- HR
- IT
- Production
- Occupational Health Center (OHC)
- Safety
External Collaborations:
- Raw Material & Packaging Material Vendors
- Housekeeping & Pest Control Teams
- Validation & Laundry Service Providers
- External Testing Laboratories
