Qc Incharge

2 months ago

Sola Ahmedabad Gujarat, India DF Pharmacy Ltd Full time

**Key Responsibilities**:1. Quality Control Operations**
- Supervise and manage the QC team and laboratory activities.
- Review and approve raw material, packaging material, and finished product testing results.
- Ensure timely and accurate testing of samples (raw materials, in-process, stability, and finished products).
- Manage the preparation and review of COAs (Certificates of Analysis).

**2. Regulatory Compliance**
- Ensure compliance with regulatory requirements (e.g., WHO GMP, USFDA, MHRA, etc.).
- Stay updated on changes in pharmaceutical quality standards and regulatory guidelines.
- Prepare for and assist during internal and external audits and inspections.

**3. Documentation and Reporting**
- Review and maintain QC documents such as test reports, stability reports, and SOPs.
- Ensure proper calibration and validation records for all QC instruments.
- Submit monthly/quarterly QC reports to the management.

**4. Team Management**
- Train and mentor QC staff on laboratory techniques, safety procedures, and compliance requirements.
- Manage workloads and allocate resources effectively.
- Conduct performance evaluations and support staff development.

**5. Laboratory Equipment and Processes**
- Oversee the procurement, maintenance, and qualification of laboratory equipment.
- Implement and monitor adherence to laboratory safety protocols.
- Ensure proper storage and use of chemicals, reagents, and reference standards.

**6. Investigation and Troubleshooting**
- Conduct investigations for OOS (Out of Specification), deviations, and laboratory errors.
- Propose CAPAs (Corrective and Preventive Actions) and ensure their implementation.

**7. Stability Studies**
- Oversee stability studies to determine product shelf life.
- Monitor the stability chamber conditions and evaluate data trends.

**8. Continuous Improvement**
- Identify opportunities to improve QC processes, reduce errors, and enhance efficiency.
- Participate in cross-departmental discussions to optimize quality practices.

**Qualifications**:

- **Education**: Bachelor’s/Master’s degree in Pharmacy, Chemistry, Microbiology, or related field.
- **Experience**: 6-10 years in pharmaceutical QC, with at least 2-3 years in a supervisory role.
- **Knowledge**:

- Hands-on experience with HPLC, GC, UV, FTIR, and other analytical instruments.
- Deep understanding of regulatory guidelines like ICH, GMP, and GLP.

**Skills Required**:

- Strong analytical and problem-solving skills.
- Excellent leadership and team management abilities.
- Proficiency in data interpretation and technical writing.
- Knowledge of LIMS (Laboratory Information Management Systems).
- Effective communication and interpersonal skills.

Pay: ₹12,511.82 - ₹43,352.52 per month

**Benefits**:

- Health insurance
- Paid sick time
- Provident Fund

Schedule:

- Day shift

**Experience**:

- total work: 4 years (required)
- pharma company: 4 years (required)

Work Location: In person

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