Qc Officer

1 week ago

Sanand, India Kashmik Formulation Private Limited Full time

We are seeking a detail-oriented and experienced **Quality Control Officer** to handle **stability testing and documentation** as per regulatory guidelines (ICH, WHO, USFDA, etc.). The role involves routine and accelerated stability studies, sample analysis, and maintaining GMP-compliant records.

**Key Responsibilities**:

- Conduct physical and chemical stability testing of drug products as per stability protocols.
- Prepare and review stability study protocols, reports, and data sheets.
- Perform routine and accelerated stability sample testing using analytical techniques (HPLC, UV, dissolution, etc.).
- Maintain stability chambers, monitor conditions, and ensure calibration and documentation.
- Follow ICH guidelines (Q1A-Q1F) and regulatory requirements for stability studies.
- Ensure timely sampling, analysis, and data entry in LIMS or related systems.
- Support investigations for OOS/OOT results and assist in CAPA implementation.
- Coordinate with QA, AR&D, and production teams for stability-related activities.
- Maintain all records and documentation as per cGMP and data integrity requirements.
- Support during regulatory audits and inspections.

**Requirements**:

- B.Sc. / M.Sc. in Chemistry, Pharmaceutical Sciences, or related field
- 1-2 years of experience in **stability testing** within a pharmaceutical QC lab
- Hands-on experience with instruments like HPLC, UV, dissolution apparatus, pH meter, etc.
- Knowledge of ICH stability guidelines and cGMP practices
- Familiarity with GLP documentation and audit readiness
- Good analytical, observation, and reporting skills

**Job Types**: Full-time, Permanent

Pay: Up to ₹25,000.00 per month

**Benefits**:

- Food provided
- Leave encashment
- Provident Fund

Work Location: In person

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