Description
Description:
Responsible for preparing, reviewing and maintaining technical and quality control documentation for Oral Solid Dosage (OSD) products, including SOPs, specifications, standard test procedures, analytical worksheets and technical reports. The role ensures that documents are scientifically accurate, clearly written and aligned with applicable pharmacopeial requirements, regulatory guidelines, Valuable Documentation Practices and internal quality standards. Collaborates with QC, QA and other relevant functions to incorporate technical inputs, address review comments and facilitate timely document approval and implementation. Supports document lifecycle management, data integrity and audit readiness through accurate, consistent and traceable documentation.
Essential Functions:
- Draft and revise SOPs, specifications, standard test procedures (STPs), analytical worksheets and technical reports.
- Review documents for technical accuracy, clarity and compliance with Good Documentation Practices.
- Coordinate with QC, QA and relevant departments for timely document approval and implementation.
- Maintain document revision history, controlled records and audit readiness.
Additional Responsibilities:
- Comply with all applicable EHS policies, SOPs, statutory requirements, and use the prescribed PPE while performing assigned duties.
- Identify and promptly report unsafe acts, unsafe conditions, near misses, incidents, and environmental hazards, and support corrective and preventive actions.
- Actively participate in EHS training, emergency preparedness, risk assessment, and continuous improvement initiatives to promote a safe, healthy, and environmentally responsible workplace.
Key Skills:
Pharmacopeial interpretation, regulatory knowledge, technical writing, analytical thinking, document control, attention to detail and effective communication; ability to work independently and collaborate across functions.
Qualifications
Education:
- M Sc. / B. Pharm - Required
- M. Pharm - Preferred
Experience:
- 5 to 8 years
Specialized Knowledge: Licenses:
📌 Officer, Quality Control, Documentation (India)
🏢 Amneal
📍 India