Quality Control HPLC Exp

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