Qc Executive

QC Reviewer / Sr. Research Associate:

Role & 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.

Preferred candidate profile

• Education:

  B.Sc / M.Sc in Chemistry / Pharmaceutical Sciences or related field.

• Experience: 4

  -8 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