Quality Assurance – Analytical QA (Senior Officer)
Company: Glenmark Healthcare Limited
Location: Dindori, Nashik, India
Function: Quality Assurance
Designation: Senior Officer
Employment Type: Full-time
Position Overview
The role focuses on Quality Assurance for Analytical Data Review within a pharmaceutical manufacturing environment. The position ensures compliance with regulatory standards through review and audit of QC laboratory data and documentation.
Key Responsibilities
1. Analytical Data Review
Review QC laboratory data including chromatographic outputs and laboratory notebooks.
Ensure compliance with cGMP, GLP, and ICH guidelines.
2. Audit & Compliance
Audit sample login records, analytical worksheets, instrument logbooks, and Certificates of Analysis (COA).
Verify accuracy and completeness of laboratory documentation.
Ensure adherence to approved SOPs and validated analytical methods.
3. Investigation & Deviation Handling
Investigate:
Out of Specification (OOS) results
Deviations
Laboratory discrepancies
Coordinate with QC analysts for resolution of issues and audit observations.
4. Documentation & SOP Management
Prepare, review, and revise:
Standard Operating Procedures (SOPs)
Specifications
Analytical Method Validation (AMV) protocols
Additional Responsibilities
Support regulatory and internal audit responses.
Maintain data integrity and GMP compliance.
Perform other tasks as assigned by reporting authority or department head.
Required Qualifications
Education
B.Sc / M.Sc / B.Pharm / M.Pharm (Full-time degree)
Experience
3 to 5 years of experience in pharmaceutical industry
Experience in:
Analytical data review
QC laboratory processes
GMP-regulated environments
Technical Skills
Knowledge of analytical instruments:
HPLC
GC
UV spectrophotometer
Auto titrator
Familiarity with:
CFR regulations
SAP or other ERP systems
Analytical method validation and QC systems
Key Competencies
Strong understanding of pharmaceutical QC processes
GMP/GLP/ICH compliance knowledge
Analytical thinking and attention to detail
Strong written and verbal communication skills
Ability to work in cross-functional and global teams
Problem-solving and investigation skills
Assertive, proactive, and detail-oriented approach
Work Environment
Office and laboratory-based interactions
Requires use of computers and laboratory documentation systems
May involve coordination with QC labs and QA teams
Other Information
Full-time permanent role
Valid work authorization required for India
Flexible role evolving with organizational needs
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