Chemistry QA Jobs at Enzene Biosciences Ltd | Apply Now
Are you looking for Chemistry QA Jobs in Pune with strong career growth in the pharmaceutical industry? This exciting opportunity for an Executive /Senior Executive – QA (IPQA – DS) is ideal for candidates seeking Executive Jobs and MSc Chemistry Jobs in Quality Assurance. If you have experience in Drug Substance (DS) manufacturing and want to build a long-term career in QA, this role could be the perfect fit.
About Enzene Biosciences Ltd
The organization operates in the pharmaceutical manufacturing sector with a strong focus on Quality Assurance and Drug Substance production. With adherence to global regulatory standards such as USFDA, EMA, and WHO guidelines, the company ensures high-quality manufacturing practices and continuous regulatory compliance. For candidates actively searching for Chemistry QA Jobs, Executive Jobs, or MSc Chemistry Jobs in Pune, this permanent opportunity in Quality Assurance offers strong career growth, regulatory exposure, and hands-on experience in DS manufacturing.
Chemistry QA Jobs – Executive / Senior Executive – QA (IPQA – DS)
Location: Pune, Maharashtra, India
Department: Quality Assurance U1
Employee Type: Permanent (ENZBIO)
Experience Range: 2–9 Years
Qualification: M.Sc / M.Pharm
This is an excellent opportunity for professionals searching
for Executive Jobs and MSc Chemistry Jobs in the Quality Assurance domain. These Chemistry QA Jobs focus on ensuring cGMP compliance at the shop floor for Drug Substance (DS) manufacturing.Job Purpose
To ensure cGMP compliance at the shop floor for Drug Substance (DS) manufacturing through effective line clearance, documentation review, in-process oversight, and quality systems activities.
Key Responsibilities
- Perform manufacturing line clearance on the shop floor for DS activities.
- Ensure proper execution and compliance of in-process checks during manufacturing operations.
- Conduct routine GMP rounds at the Drug Substance facility and document observations.
- Review online batch manufacturing records (BMR) for accuracy, completeness, and compliance.
- Review and approve process validation protocols and reports, cleaning validation protocols and reports.
- Review and manage Standard Operating Procedures (SOPs) and other protocols/reports related to shop floor operations.
- Coordinate collection and submission of samples as per BMR, specifications, process validation, and stability protocols.
- Perform regular shop floor compliance rounds to ensure adherence to cGMP and follow up on corrective actions.
- Prepare and support Annual Product Quality Review (APQR/PQR) documents.
- Initiate and manage Change Control, Deviations, Incidents, and CAPA, including investigation support and timely closure.
- Participate in QMS investigations and root cause analysis.
- Ensure continuous cGMP compliance and regulatory readiness at the shop floor.
- Perform risk assessments for critical manufacturing and quality processes.
These Chemistry QA Jobs require strong shop floor exposure and documentation expertise in Drug Substance manufacturing.
Skills & Competencies
- Strong knowledge of cGMP, QMS, and regulatory requirements
- Hands-on experience with DS/DP shop floor QA activities
- Understanding of process validation, cleaning validation, and in-process controls
- Experience in BMR review and documentation control
- Good analytical, investigative, and problem-solving skills
- Effective communication and coordination with cross-functional teams
Candidates looking for Executive Jobs in Quality Assurance with strong regulatory exposure will find this opportunity highly suitable.
Regulatory Exposure (Preferred)
- USFDA
- EMA
- WHO
- Other global regulatory guidelines.
