Quality Control Hplc Exp

6 days ago

Nalagarh, India Elfin Pharma Full time

**Key Roles and Responsibilities**:1. **HPLC Operation & Analysis**
- Routine operation of HPLC for raw materials, in-process, finished products, and stability samples.
- Method development and validation as per pharmacopeia or client requirements (if applicable).
- Troubleshooting HPLC instruments and resolving minor errors.
- Calibration and qualification of HPLC instruments as per schedule.

2. **Sample Management**
- Receiving, labeling, and maintaining records of incoming samples.
- Performing chemical and instrumental analysis of raw materials, intermediates, and finished goods.
- Maintaining proper documentation of sample testing, observations, and results.

3. **Documentation & Compliance**
- Preparation and review of Standard Operating Procedures (SOPs), test procedures, and calibration protocols.
- Ensuring all testing is done as per GMP, GLP, and regulatory compliance.
- Proper entry of data in analytical records, logbooks, and electronic systems (if any).

4. **Quality Assurance Support**
- Investigate out-of-specification (OOS) and out-of-trend (OOT) results related to HPLC testing.
- Supporting deviation handling, change control, and CAPA related to QC activities.

5. **Equipment Maintenance**
- Performing routine preventive maintenance of HPLC and other QC instruments.
- Coordinating with service engineers for major repairs and breakdowns.

6. **Training & Development**
- Training new joiners or junior analysts on HPLC operation and lab safety practices.
- Continuously updating self on regulatory guidelines, pharmacopeial updates, and new technologies.

7. **Regulatory & Audit Compliance**
- Ensure readiness for regulatory audits like USFDA, MHRA, WHO, or client audits.
- Participate in internal audits and implement corrective actions.

8. **Safety & Housekeeping**
- Following all lab safety protocols.
- Maintaining cleanliness and orderliness of the QC lab area.

**Preferred Skills and Qualifications**:

- B.Sc / M.Sc in Chemistry, Pharmaceutical Sciences, or equivalent.
- 2-5 years experience in QC department with hands-on experience in HPLC operation.
- Familiarity with software like Empower, LabSolutions, or Chromeleon (if applicable).
- Knowledge of regulatory requirements (GMP, GLP).

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

Pay: ₹16,745.43 - ₹30,694.27 per month

**Benefits**:

- Paid sick time
- Paid time off
- Provident Fund

Schedule:

- Day shift

Supplemental Pay:

- Yearly bonus

Work Location: In person

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