Senior Executive, Quality Control
Company: Not Specified
Location: Dahej SIR, Gujarat, India
Job Type: Full-Time
Experience: Typically 6–12+ Years (Quality Control / Pharmaceutical Analysis)
Qualification: B.Sc / B.Pharm (M.Sc / M.Pharm Preferred)
Salary Range: Not Specified
Job Overview
The company is hiring a Senior Executive, Quality Control responsible for performing complex analytical testing on pharmaceutical materials and products, maintaining laboratory compliance, and ensuring high-quality, accurate data in accordance with regulatory and company standards.
The role involves method verification, transfer, and validation, stability studies, operation and maintenance of analytical instrumentation, documentation, laboratory safety, CAPA implementation, and continuous improvement activities including mentoring and training.
Key Responsibilities
Analytical Testing & Methodology
Perform routine and non-routine testing using techniques such as HPLC, UPLC, GC, Dissolution, UV-Vis, FT-IR, Karl Fischer, LCMS, GCMS, XRPD, ICP-MS.
Support method verification, transfer, and validation activities.
Conduct stability studies and analyze raw materials, packaging materials, and finished products.
Troubleshoot analytical methods and instrumentation as required.
Laboratory Operations & Instrumentation
Operate, maintain, calibrate, and qualify analytical instruments, including sophisticated equipment.
Ensure proper functionality of laboratory instruments and maintain equipment records.
Monitor inventory of chemicals, working/reference standards, and reagents.
Manage sample collection, storage, and disposal in compliance with SOPs and safety guidelines.
Quality & Compliance
Ensure adherence to cGMP, GLP, and SOPs.
Document testing results accurately following GDP and ALCOA principles.
Identify, investigate, and report OOS, OOT, and atypical results; implement CAPAs.
Prepare SOPs, laboratory-related documents, and analytical reports, including Certificates of Analysis.
Safety & Laboratory Maintenance
Maintain a clean and safe laboratory environment.
Ensure proper handling and disposal of chemicals and samples.
Monitor laboratory safety, participate in audits, and support inspection readiness.
Training & Mentorship
Provide guidance and training to junior analysts.
Contribute to process improvements and best practices.
Stay current with regulatory updates and participate in training programs.
Additional Responsibilities
Coordinate external laboratory testing when required.
Prepare and standardize volumetric solutions/reagents.
Supervise daily quality control laboratory activities.
Any other tasks assigned by the HOD.
Required Skills
Analytical Testing & Evaluation
Advanced expertise in analytical testing and data interpretation.
Proficiency with both simple and sophisticated analytical instruments.
Quality Control & Compliance
Strong knowledge of QC processes, documentation, and data integrity.
Understanding of regulatory guidelines and compliance requirements.
Laboratory Management
Instrument calibration, maintenance, and qualification.
Stability study documentation and method validation/verification.
LIMS operation and data management.
Problem-Solving & Continuous Improvement
Troubleshooting analytical methods and instruments.
Investigating quality issues and implementing corrective actions.
Basic Qualifications
B.Sc / B.Pharm (M.Sc / M.Pharm preferred)
6+ years of relevant experience in pharmaceutical quality control
Preferred Competencies
Expertise in analytical techniques and QC processes
Knowledge of cGMP, GLP, and regulatory standards
Experience in laboratory supervision and mentoring
Key Competencies
Analytical testing and method development
Quality control and compliance management
Laboratory operations and instrumentation
Documentation, data integrity, and reporting
Training, mentorship, and continuous improvement
About the Company
Not Specified
Uttar Pradesh :
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Siliguri |Illinois :
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Canada |Quebec :
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