QA (Stability) - Executive

2 weeks ago

Una, India Stanford Laboratories Full time

Job Description Roles & Responsibilities: - Ensure proper operation and cleaning of equipment and manufacturing areas related to Granulation, Compression, Coating, and Capsule Filling processes. - Handle Change Control, Deviation, Incident, and Market Complaint activities in compliance with company procedures and regulatory guidelines. - Maintain sound knowledge and implementation of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) across manufacturing activities. - Prepare and review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and relevant Standard Operating Procedures (SOPs). - Participate in equipment and area qualification and ensure validation activities are conducted as per approved protocols and GMP standards. - Support in maintaining documentation for validation, qualification, and other manufacturing compliance records. - Coordinate with cross-functional teams to ensure smooth manufacturing operations and compliance with regulatory requirements. Desired Candidate Profile: - Qualification: B. Pharma - Experience: 3 to 5 years of relevant experience in a similar role within a pharmaceutical formulation unit. - Strong understanding of OSD manufacturing processes, GMP, and GDP. - Good documentation, communication, and coordination skills.

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