Senior Quality Control Engineer

4 weeks ago

Gandhinagar, Gujarat, India Gopani Product Systems Pvt Limited Full time
Location: Gandhinagar, Gujarat (On-site)
Job Title: Quality Control (QC) Engineer – Cleanroom Unit
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)
Candidates must have experience in at least one of the following regulated sectors:
Sterile/Injectables Manufacturing
Medical Devices Manufacturing
Medicinal Equipment Manufacturing
Position Overview
We are seeking a proactive and detail-oriented QC Engineer with 3–5 years of experience in sterile, cleanroom, or regulated manufacturing environments. The role focuses on maintaining product quality through rigorous testing and adherence to GMP standards.
Key Responsibilities
Conduct testing of raw materials, in-process samples, and finished products per pharmacopeial guidelines (IP/BP/USP/Ph. Eur.).
Perform assays, dissolution, impurity profiling, and other pharmacopeial tests.
Carry out wet chemistry procedures, including pH and conductivity testing.
Operate and calibrate analytical instruments (IR, FTIR, etc.).
Ensure compliance with GMP, GLP, and SOPs.
Maintain accurate documentation: test reports, calibration logs, change controls, etc.
Collaborate with QA and Production teams.
Support audit readiness and participate in internal/external audits.
Handle sample collection, labeling, storage, and assist with stability studies.
Candidate Requirements
Education (Preferred):
B.Sc / M.Sc in Chemistry
B.Pharm / M.Pharm (Pharmaceutical Chemistry)
Experience:
3–5 years in a pharmaceutical or regulated manufacturing setup
Prior work in sterile/medical device/cleanroom environments is essential
Technical Skills:
Proficient in pharmacopeial testing and documentation
Skilled with IR Spectroscopy, FTIR, pH/conductivity meters
Familiar with method validation and instrument calibration
Strong understanding of GMP, data integrity, and cleanroom compliance
Application Process
Eligible candidates may share their updated CV at
Subject Line: Application for QC Engineer – Sterile/Medical Devices
Candidates matching at least 70% of the JD criteria will be considered.
Industries We Operate In
Plastics Manufacturing
Pharmaceutical Manufacturing
Medical Equipment Manufacturing

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