Department: Quality Control (Pharmaceutical)

Qualification: B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry / Analytical Chemistry / Pharmaceutical Sciences)

Reports to: QC Manager / Designee

Job Summary

We are looking for an experienced Sr. QC Officer to carry out analytical testing of raw materials, water monitoring samples, finished products and stability samples. The role includes operating QC instruments, supporting method development, validation and verification, and ensuring GMP, GLP and data integrity compliance. The candidate must be able to work independently and complete testing within defined timelines.

Roles and Responsibilities

1. Sampling and Analysis

- Sample and analyse raw materials and water monitoring samples, where applicable.
- Test according to approved specifications, analytical test procedures, SOPs and current pharmacopoeial methods.
- Carry out chemical, physical and instrumental analysis.
- Perform assay, dissolution, disintegration, related substances/impurities, identification, pH, moisture/LOD, weight variation and other applicable tests.
- Prepare standard and sample solutions accurately and perform required dilutions.

1. Instrument Handling and Calibration

- Operate HPLC, UV-Visible spectrophotometer, dissolution apparatus, disintegration tester, pH meter, analytical balance, moisture analyzer and other instruments, as trained and authorized.
- Ensure instruments are within calibration/qualification status before use.
- Perform routine checks and calibration/verification activities as assigned.
- Maintain instrument usage records and logbooks.
- Report instrument malfunction, breakdown or abnormal observations to the supervisor.
- Assist in instrument qualification, calibration and preventive maintenance.

1. Reagents, Standards and Solutions

- Prepare and standardize reagents, volumetric solutions and mobile phases as per approved procedures.
- Maintain labels, preparation records and expiry/retest information.
- Handle reference and working standards appropriately, and maintain standard inventory and usage records.
- Maintain preparation and usage records for working reference standards (WRS).
- Ensure traceability of samples, standards, reagents and solutions.
- Ensure proper storage and disposal of chemicals and laboratory waste.

1. Documentation and Data Integrity

- Record all observations and results contemporaneously in approved formats.
- Maintain analytical worksheets, raw data, instrument printouts and chromatograms.




- Follow Good Documentation Practices (GDP): entries must be attributable, legible, contemporaneous, original, accurate and complete (ALCOA+).
- Ensure proper completion and review of analytical reports and Certificate of Analysis (COA) data.
- Review chromatograms, calculations, system suitability and analytical results.
- Ensure compliance with data integrity requirements.

1. OOS, OOT and Investigations

- Immediately report atypical, unexpected, OOS and OOT results to the supervisor.
- Do not repeat, invalidate or discard any result without following the approved investigation procedure.
- Assist in laboratory investigations, deviations and analytical failures.
- Review calculations, instrument performance, standards, reagents, sample preparation and system suitability.
- Provide accurate supporting data for investigations.

1. Method Development, Validation and Verification

- Perform method development and optimization for assay, related substances, dissolution, identification and other tests.
- Prepare and execute analytical method validation and verification as per approved protocols.
- Perform forced degradation and stability-indicating method studies where applicable.
- Prepare and compile protocols, reports, worksheets and laboratory notebooks.
- Maintain traceability and documentation of development and validation activities.
- Troubleshoot HPLC, UV, dissolution apparatus and other instruments.

1. Stability Testing

- Analyse stability samples according to the approved stability protocol and schedule.
- Ensure samples are tested within the defined testing window.
- Maintain stability sample records and analytical documentation.
- Report any abnormal trend or result to the Manager/designee.

1. GMP, Safety and Compliance

- Follow current GMP, GLP requirements and laboratory SOPs.
- Maintain laboratory cleanliness and valuable housekeeping.
- Follow safety procedures when handling chemicals, solvents and equipment.
- Follow EHS requirements and use appropriate PPE.
- Participate in internal, customer and regulatory inspections/audits.
- Report deviations, incidents,



equipment problems and laboratory abnormalities promptly.

1. General Responsibilities

- Complete assigned testing within required timelines.
- Coordinate with Production, QA, Warehouse, R&D; and other departments when required.
- Participate in laboratory training programs.
- Keep current with analytical procedures and applicable pharmacopoeial requirements (IP, BP, USP).
- Perform any other QC-related duties assigned by the manager/designee.

Preferred Candidate Profile

- Education: B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry or related discipline).
- Experience: 3 to 7 years in a pharmaceutical QC laboratory (finished product, raw material, stability and/or method validation).
- Hands-on experience with HPLC (preferably Empower/ChemStation/LabSolutions), UV-Vis, dissolution and other QC instruments.
- Good understanding of GMP, GLP, GDP and data integrity (ALCOA+).
- Experience handling OOS/OOT/deviation investigations and audit support (USFDA, WHO, MHRA, EU-GMP, etc.) is preferred.
- Exposure to method development, validation/verification and forced degradation studies is an advantage.
- Familiarity with pharmacopoeial standards (IP / BP / USP / Ph. Eur.).
- Strong analytical, documentation and time-management skills.
- Ability to work independently and in a team, and to meet deadlines.
- Candidates from a regulated pharmaceutical formulation/OSD plant background are preferred.

Key Skills

Technical Skills

- HPLC operation, troubleshooting and chromatographic data review
- UV-Visible spectrophotometry
- Dissolution and disintegration testing
- Assay, related substances, identification, LOD/moisture, pH, weight variation
- Raw material, water and stability sample analysis
- Analytical method development, validation and verification
- Forced degradation / stability-indicating methods
- Preparation of standards, reagents, volumetric solutions and mobile phases
- Reference/working standard management
- Instrument calibration, verification and logbook maintenance

Compliance Skills

- cGMP, GLP, GDP and data integrity (ALCOA+)
- OOS / OOT / deviation / incident handling
- COA preparation and review
- Audit readiness and inspection support
- Pharmacopoeial knowledge (IP, BP, USP)

Soft Skills

- Attention to detail and accuracy
- Problem-solving and analytical thinking
- Time management
- Communication and cross-department coordination
- Teamwork and willingness to learn

📌 Sr. QC Officer (Vadodara)
🏢 RENOWN PHARMACEUTICALS
📍 Vadodara