Senior Quality Control Engineer

Location: Gandhinagar, Gujarat (On-site)

Job Title: Quality Control (QC) Engineer - Cleanroom Unit

Position Details

• Department:

  Quality Control

• Reporting To:

  Senior QC Engineer

• Experience Required:

  3–5 years

• Employment Type:

  Full-time

• Working Days:

  6 days/week

• Compensation:

  ₹6 – ₹6.5 LPA

Industry Preference (Mandatory)

must have prior work experience

• Sterile/Injectables Manufacturing

• Medical Devices Manufacturing

• Medicinal Equipment Manufacturing

Position Overview

Quality Control (QC) Engineer

The ideal candidate will have hands-on expertise in chemical analysis, pharmacopeial testing, and GMP-compliant documentation, especially within a sterile or cleanroom environment.

Key Responsibilities

• Conduct routine testing of raw materials, in-process samples, and finished products in accordance with pharmacopeial guidelines (IP/BP/USP/Ph. Eur.).
• Perform detailed

  Pharma Copea Testing

  including identification, assay, dissolution, impurity profiling, and other analytical parameters.
• Execute general wet chemistry procedures along with

  pH

  and

  conductivity testing

  .
• Operate and calibrate analytical instruments including

  IR Spectroscopy

  ,

  STIR

  , and related chemical analysis equipment.
• Ensure strict compliance with

  Good Manufacturing Practices (GMP)

  ,

  Good Laboratory Practices (GLP)

  , and internal

  Standard Operating Procedures (SOPs)

  .
• Maintain complete and accurate documentation including test reports, calibration records, instrument logs, and change control records.
• Support investigations related to

  Out of Specification (OOS)

  and

  Out of Trend (OOT)

  results, including root cause analysis and CAPA.
• Liaise with

  Quality Assurance (QA)

  ,

  Production

  , and

  R&D

  teams for resolution of analytical issues and technical support.
• Prepare for and participate in internal and external audits, ensuring full laboratory compliance and readiness.
• Manage sample collection, labeling, storage, and contribute to

  stability studies

  where applicable.

Candidate Requirements

Educational Qualification (Preferred):

• B.Sc / M.Sc in Chemistry
• B.Pharm / M.Pharm with a focus on Pharmaceutical Chemistry

Experience:

• 3–5 years of relevant experience in a pharmaceutical or regulated manufacturing environment
• Must have worked in

  Sterile

  ,

  Injectables

  ,

  Medical Devices

  , or

  Medical Equipment

  manufacturing

Technical Skills:

• In-depth knowledge of pharmacopeial testing methods and documentation practices
• Hands-on experience with IR Spectroscopy, STIR, pH meters, and conductivity meters
• Familiarity with analytical method validation and instrument calibration
• Strong understanding of

  Data Integrity

  ,

  GDP (Good Documentation Practices)

  , and compliance in regulated cleanroom settings

Application Process

hr2@gopani.com

Subject Line:

Industries We Operate In

• Plastics Manufacturing

• Pharmaceutical Manufacturing

• Medical Equipment Manufacturing

Even if a candidate matched the 70% of the JD can be considered for the role.