Job Descriptions – Quality Department Roles
Position: QC Executive / Senior Executive – Quality Control
- Experience Required: 6–8 Years
Key Responsibilities
Operation, calibration, and routine maintenance of analytical instruments such as HPLC, GC, UV, FTIR, KF, Dissolution apparatus, etc.
Perform analysis of raw materials (RM), in‑process samples (IP), finished products (FP), cleaning samples, stability samples.
Maintain documentation including equipment logbooks, calibration records, test data sheets, and analytical reports.
Preparation and qualification of working standards, reference standards, primary standards.
Support Analytical Method Transfer (AMT) and Analytical Method Validation (AMV) for API and formulations.
Review analytical results, prepare analytical reports and Certificates of Analysis (COA).
Conduct analyst qualification, training, and compliance with GLP & GMP.
Handle incidents, deviations, OOS, OOT, and perform associated investigations.
Coordinate accelerated and real‑time stability studies and compile stability summaries.
Ensure compliance with regulatory guidelines (cGMP, GLP, ICH) and maintain controlled documents such as SOPs, STPs, Specifications.
Position: Executive – Validation (Quality Assurance)
- Experience: 5–7 Years
Key Responsibilities
Execution and review of Process Validation, including PPQ & commercial validation activities.
Perform and document Cleaning Validation and verify cleaning effectiveness.
Coordinate and execute Media Fill / Aseptic Process Simulation (APS) as per regulatory norms.
Involvement in Quality Management Systems (QMS) activities—Change Control, CAPA, Deviations, Risk Assessment.
Perform Equipment & Utility Qualification (IQ/OQ/PQ).
Assist in validation activities for HVAC systems, Water systems (PW/WFI), compressed air, and facility qualifications.
Position: Executive – IPQA (Quality Assurance)
- Experience: 5–7 Years
Department: Quality Assurance – IPQA (Injectables)
Key Responsibilities
Oversee IPQA activities during manufacturing & packaging for injectable products.
Monitor adherence to cGMP/GDP during all production and packing processes.
Review and approve BMR/BPR, ensuring correctness and completeness of batch documentation.
Handle deviations, CAPA, change controls, and maintain audit readiness.
Perform line clearance, in‑process checks, sterility assurance, environmental monitoring compliance review, etc.
Coordinate with the production team to ensure real‑time quality oversight.
Lead IPQA initiatives to strengthen continuous improvement and regulatory compliance.
Ensure adherence to QMS requirements for sterile manufacturing.
Step 1: Submit your details here:
https://lnkd.in/gZDrmjhb
Step 2: Share your updated CV to:
hr1@zenotech.co.in
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