11 Nov
|
RPG Group
|
India
• Maintain and control SOPs, protocols, reports, formats and other QA documents.
• Ensure preparation, review, approval, issuance and distribution of controlled documents.
• Maintain document issuance, revision history and archival records.
• Ensure timely review and revision of SOPs and other controlled documents.
• Maintain proper documentation practices as per cGMP and ALCOA+ guidelines.
• Coordinate with various departments for document preparation, review and approval.
• Maintain document master lists and ensure obsolete documents are withdrawn.
• Handle document retrieval during internal audits, external audits and regulatory inspections.
• Maintain training records related to SOP revisions and new document implementation.
• Ensure compliance with GDP (Good Documentation Practices)
and data integrity requirements. Required Qualifications
• B.
Pharm / M.
Pharm / B.
Sc / M.
Sc.
• Relevant experience in Quality Assurance – Documentation Control in a pharmaceutical formulation company. Required Experience
• 2–5 years in QA Documentation Control.
• Experience in OSD (Oral Solid Dosage) manufacturing preferred. Key Skills
• Knowledge of cGMP, GDP and ALCOA+.
• SOP preparation and document lifecycle management.
• Document issuance, archival and retrieval.
• Audit documentation handling.
• Positive coordination and communication skills.
• Knowledge of MS Office.
📌 Executive (India)
🏢 RPG Group
📍 India