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]

Job SummaryWe are looking for a skilled and detail-oriented Senior Executive – Analytical QA to review and verify analytical data and laboratory documents generated by the Quality Control (QC) department. The candidate will ensure compliance with cGMP, data integrity requirements, and applicable regulatory guidelines. The role also involves identifying discrepancies, reviewing analytical investigations, and supporting new product development activities.

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 recent product development is an added advantage.

· Experience in analytical data review, HPLC/GC data verification, and regulatory documentation will be preferred.

Post-Joining ExpectationsWithin 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 new product development activities.

📌 QA – QMS / Qualifications & Validations – OSD (Jadcherla)
🏢 Sri Ambikare Pharma
📍 Jadcherla