Job Purpose
To ensure the accuracy, completeness, and compliance of all Quality Control documentation and test results as per current Good Laboratory Practices (cGLP), regulatory guidelines, and internal SOPs before final release or submission.
Key Responsibilities
- Review analytical raw data, calculations, and reports for accuracy, completeness, and compliance with approved specifications and methods.
- Ensure all laboratory documentation meets regulatory and internal quality standards (e.g., USFDA, EU-GMP, ICH, WHO, etc.).
- Review chromatographic data (HPLC, GC), wet chemistry reports, and other analytical test results.
- Verify results for routine analysis, stability studies, and validation reports.
- Check instrument calibration records and ensure compliance before reviewing analytical results.
- Identify and report any data discrepancies, deviations, or non-conformities.
- Review and verify entries in logbooks, worksheets, and other controlled documents.
- Assist in investigations related to out-of-specification (OOS), deviations, and laboratory incidents.
- Coordinate with analysts and the QA team to ensure timely corrections or clarifications.
- Ensure timely completion and archival of reviewed documents.
- Provide support during internal and external audits (regulatory and customer).
- Participate in continuous improvement initiatives within the QC function.
Key Requirements- Education: B.Sc / M.Sc in Chemistry / Pharmaceutical Sciences or related field.
- Experience: 58 years of experience in Quality Control, preferably in API manufacturing. At least 2 years in a QC Reviewer role.
- Technical Skills:
- Hands-on experience and data interpretation of analytical instruments like HPLC, GC, FTIR, UV, KF, etc.
- Thorough understanding of cGMP, GLP, and regulatory requirements.
- Good documentation and analytical skills.
Key Competencies
- Attention to detail
- Strong analytical and problem-solving skills
- Good communication and interpersonal skills
- Ability to manage priorities and meet deadlines
- High integrity and compliance mindset
Skills: analytical skills,team collaboration,cgmp,glp,time management,quality control,hplc,gc,kf,ftir,technical proficiency,regulatory compliance,uv,documentation,data interpretation
