Pharma QC Officer
2 weeks ago
Position: Pharma Quality Control Officer - FDA Schedule M Documentation
Qualification: Min. B. Pharma degree (mandatory)
Location: Gurgaon, Haryana
Experience: Min. 3 years
Salary: Open/Negotiable - based on qualification, experience, and candidates expectation. Candidates are requested to mention their expected salary in the application / resume.
Key Responsibilities:
- Ensure compliance with Schedule M requirements as per FDA and company SOPs.
- Prepare, review, and update QC/QA and other records, logbooks, and test reports.
- Maintain and review proper documentation in accordance with FDA Schedule M regulatory standards.
- Conduct sampling, testing, and analysis of raw materials, in-process materials and finished products.
- Calibrate, operate, and maintain analytical instruments like - HPLC, GC-MS, UV etc.
- Monitor and ensure adherence to company quality standards across all departments.
- Coordinate with QA for deviations, OOS, and CAPA documentation.
- Assist in regulatory audits and internal quality audits.
- Ensure proper data integrity, record-keeping, and sample management.
Desired Candidate Profile:
- B.Pharma degree (mandatory).
- Knowledge of Schedule M and FDA documentation requirements.
- Strong understanding of cGMP, GLP, and regulatory expectations.
- Good analytical skills and attention to detail.
- Proficient in documentation and compliance handling.
- Experience with pharma QC instruments preferred.
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