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Quality Control
ConfidentialAhmedabad13 days ago
Job descriptionDocument study protocols, deviations, results, and reports. Maintain comprehensive stability study records for internal reference and regulatory submissions. Prepare stability data for inclusion in regulatory filings, ensuring compliance with ICH, FDA, or other relevant guidelines. Ensure that all documents are stored according to GMP and are easily retrievable during audits. Well-versed with Chromeleon Software Performing a Dissolution Test Well-versed with QC lab Instruments Work closely with Production, QA, Engineering, and Warehouse teams to ensure smooth operations. Support QMS activities Ensure adherence to aseptic techniques and environmental monitoring standards in cleanrooms. Follow safety protocols for handling hazardous chemicals and sterilization processes. Train production staff on GMP, hygiene, and workplace safety standards. Education : B.Pharm / M.Pharm / M.Sc Experience : 2-7 years of experience in QC Stability Section for Formulation (preferably injectables) Technical Skills : Well-versed with Chameleon Software Performing a Dissolution Test Familiarity with cGMP, USFDA, EU-GMP, and WHO-GMP guidelines. Soft Skills : Strong problem-solving abilities, teamwork, attention to detail, and adaptability.
Key Responsibilities :
1. Stability Study Design & Planning
- Define study protocols, including time points, conditions (temperature, humidity, light exposure), and container types.
- Collaborate with formulation scientists and regulatory affairs teams to ensure studies align with regulatory guidelines (e.g., ICH, FDA).
- Plan long-term and accelerated stability testing for new and existing products
2. Compliance & Documentation
3. Equipment & Process Management
4. Cross-functional Coordination
5. Safety & Hygiene Compliance
Required Qualifications & Skills :
Skills Required
Hplc, Dissolution, Glp, Gc, stability testing , Quality Control
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Quality Control • Ahmedabad
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