Department: Quality Assurance (Analytical QA)

Location:
Mahabubnagar, Telangana

Experience:
Relevant experience in Analytical QA or QC Qualification: M.
Sc. Chemistry / M.
Pharm / B.
Sc. Chemistry Employment Type: Permanent Joining: Immediate joining Interested candidates can share their updated resumes at: Email: [email protected]

Key Responsibilities
• Review and verify analytical data, raw data, chromatograms, calculations, worksheets, and laboratory records.
• Review analytical results generated using HPLC, GC, UV, dissolution, and other laboratory instruments.
• Verify assay, related substances, dissolution, content uniformity, and other analytical test results.
• Review Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, root cause analysis, and CAPA documentation.
• Review analytical method validation, verification, method transfer, and stability study documents.
• Ensure compliance with cGMP, GLP, SOPs, pharmacopoeial standards, and applicable regulatory guidelines.
• Verify data integrity and ensure proper maintenance of electronic and paper records, including audit trail review where applicable.
• Review stability data, trends, specifications, and analytical reports for Oral Solid Dosage (OSD) products.
• Identify documentation errors, analytical discrepancies, and compliance gaps and communicate them to the concerned team.
• Coordinate with QC and other departments to ensure timely completion of analytical reviews.
• Support analytical documentation and review activities related to new product development. Required Mandatory Skills




• Good knowledge of pharmaceutical analytical processes and laboratory practices.
• Understanding of HPLC, GC, UV, and dissolution analysis.
• Ability to review chromatograms, analytical raw data, calculations, and specifications.
• Knowledge of OOS/OOT investigations, CAPA, and data integrity requirements.
• Good documentation, analytical thinking, and communication skills.
• Ability to identify errors and ensure compliance with quality procedures. Experience Requirements
• Experience in pharmaceutical QC or Analytical QA is preferred.
• Experience in Oral Solid Dosage (OSD), pellets, and new product development is an added advantage.
• Experience in analytical data review, HPLC/GC data verification, and regulatory documentation will be preferred.
• Experience Requirements
• Experience in pharmaceutical QC or Analytical QA is preferred.
• Experience in Oral Solid Dosage (OSD), pellets, and new product development is an added advantage.
• Experience in analytical data review, HPLC/GC data verification, and regulatory documentation will be preferred. Post-Joining Expectations Within the first two months, the candidate should be able to:
• Independently review analytical data and verify related documents.
• Understand departmental SOPs, regulatory requirements, and quality systems.
• Manage and prioritize assigned analytical review activities.
• Identify analytical discrepancies and documentation gaps and report them promptly. Support the timely completion of analytical reviews, especially for current product development activities.

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