Quality Control HPLC Exp

2 - 5 years

2 - 3 Lacs

Posted:3 weeks ago| Platform: GlassDoor logo

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Work Mode

On-site

Job Type

Full Time

Job Description

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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