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.
- Valuable 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 new product development activities.
📌 Quality Assurance (Analytical QA) (Jadcherla)
🏢 Sri Ambikare Pharma
📍 Jadcherla