Pharma QC Officer (FDA Schedule M Documentation) (B.Pharma Mandatory)

3 - 8 years

3 - 4 Lacs

Posted:1 day ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Position:

Location:

Salary:

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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