Executive - Quality Control, Pharma

Zentiva; Ankleshwar; On-site; INR 600,000 - 900,000; Full time

Job summary

Zentiva in Ankleshwar, Gujarat, India seeks an Executive – Quality Control to implement QC activities in a GMP/GLP environment, ensuring consistent product quality and regulatory compliance while coordinating with production and warehouse.

The ideal candidate holds M.Sc (Organic/Analytical Chemistry) or B.Pharm with 5–8 years of pharma/API lab experience, and has hands-on knowledge of GMP/GLP, LIMS and QMS.

Qualifications

• M.Sc in Organic/Analytical Chemistry or B.Pharm with 5–8 years pharma/API lab experience.
• GMP & GLP knowledge essential.
• Strong coordination and communication skills.
• Experience with LIMS and QMS.

Responsibilities

• Perform sampling and analysis of raw materials, in-process, finished products.
• Analyze stability, process validation samples, and cleaning validation.
• Operate and maintain laboratory instruments (HPLC, GC, UV/IR, Dissolution, auto-titrator, polarimeter).
• Calibrate and maintain lab equipment; assist qualification.
• Prepare SOPs, maintain records, manage reagents.
• Coordinate with production and warehouse for analytical activities.
• Ensure HSE compliance in QC lab.
• Investigate out-of-specification results and maintain audit-ready data.

Skills

GMP & GLP knowledge

Coordination & communication

Analytical ability

LIMS & QMS knowledge

Education

M.Sc (Organic / Analytical Chemistry)

B. Pharm

Tools

HPLC

GC

UV/Vis spectrophotometer

IR spectrophotometer

Dissolution tester

Auto-titrator

Polarimeter

Job description

Position Title

Executive – Quality Control

Qualification And Experience

M. Sc (Organic / Analytical Chemistry) / B. Pharm with 5 - 8 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge

Job Overview

• Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements.

Responsibilities

• Analysis:

  Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples.

  Performing analysis of Stability, process validation samples, and Cleaning Validation.

  Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc.

• Good Laboratory Practice:

  Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment.

  Knowledge on the preparation of SOPs and Formats and Analytical Test records.

  Managing reference standards, working standards, laboratory reagents & chemicals.

  Arranging and observing Control Samples and maintaining the record.

  Participating in the Investigation of out-of-specification results.

  Maintaining laboratory raw data related to testing activity.

• Validation:

  Performing Analytical Method validation, cleaning validation as per the protocol.

• Other:

  Coordinating with production and the warehouse for analytical activities.

  Compliance to HSE Requirements for QC laboratory.

  Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations.

  Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities.

Requirements

• GMP & GLP knowledge
• Good coordination & communication skills.
• Analytical ability
• Knowledge on LIMS & QMS

What makes this position unique?

• This position will provide good exposure to work in GMP/ GLP environment.

Location information

Ankleshwar, Gujarat, India