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 sanskriti.rai@gopani.com

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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