QA Executive (Mumbai)

QA Executive (Mumbai)

02 Oct
|
Mumbai Biocluster
|
Mumbai

02 Oct

Mumbai Biocluster

Mumbai

Hiring: QA Executive | Mumbai BioCluster

Location: Matunga, Mumbai

Work Mode: In-person

Experience: 1–2 years of relevant industrial experience – Mandatory

Mumbai BioCluster is looking for a QA Executive to strengthen our Quality Assurance function across laboratory, research, and operational activities.

The ideal candidate will have hands-on exposure to Quality Management Systems (QMS), document control, Good Documentation Practices (GDP), deviations, CAPA, audits, and quality compliance in an industrial, pharmaceutical, biotech, CRO/CDMO, laboratory, or research environment.

Key Responsibilities

Quality Management System (QMS)

- Support implementation, maintenance, and continuous improvement of the QMS.
- Monitor compliance with SOPs, quality procedures, and applicable guidelines.
- Identify quality gaps and coordinate corrective actions.

Document Control & GDP

- Prepare, review, maintain, and control SOPs, work instructions, forms, checklists, and quality documents.
- Manage document issuance, revision, approval, version control, archival, and retrieval.
- Maintain controlled-document registers and ensure obsolete documents are appropriately withdrawn.
- Ensure adherence to Good Documentation Practices.

Deviations & CAPA

- Coordinate documentation and tracking of deviations, non-conformances, observations, and CAPAs.
- Support root-cause investigations and corrective/preventive action plans.
- Monitor CAPA implementation and ensure timely closure.

Audits & Compliance

- Support internal audits, audit preparation, documentation, and follow-up.
- Assist with external audits and compliance assessments.
- Track and support closure of audit observations.

Laboratory & Equipment Quality

- Maintain quality documentation related to laboratory activities, equipment calibration, maintenance, and qualification.




- Coordinate with laboratory teams to ensure required quality records are complete and up to date.

Quality Reporting & Coordination

- Maintain quality trackers and databases for documents, deviations, CAPAs, audits, and compliance activities.
- Prepare periodic quality reports and management updates.
- Coordinate with Scientific, Laboratory, Research, Operations, and Administration teams on quality-related activities.

Training & Quality Awareness

- Support quality-related training and maintain training records.
- Assist in promoting GDP, SOP compliance, and quality awareness across teams.

Required Qualifications
- Bachelor's or Master's degree in Pharmacy, Biotechnology, Biochemistry, Microbiology, Chemistry, Life Sciences, or a related field.
- 1–2 years of relevant industrial experience in Quality Assurance is mandatory.
- Experience in pharmaceutical, biotech, CRO/CDMO, laboratory, R&D;, or a related industrial environment will be preferred.
- Working knowledge of QMS, GDP, GMP/GLP principles, and quality documentation.
- Good working knowledge of MS Word and MS Excel.
- Exposure to document control, audits, deviations, CAPA, and quality trackers will be an advantage.

Key Competencies ✔ Strong attention to detail

✔ Quality and compliance orientation

✔ Excellent documentation and record-management skills

✔ Analytical and problem-solving ability

✔ Strong follow-up and accountability

✔ Good written and verbal communication

✔ Cross-functional coordination skills

✔ Ability to work independently and systematically

✔ Proactive approach to identifying quality gaps

What You Can Expect

- Exposure to QMS and quality systems in an R&D; and industry-facing environment
- Prospect to work closely with scientific and laboratory teams
- Hands-on exposure to audits, CAPA, documentation, compliance, and quality improvement initiatives
- Flexible schedule

Pay: ₹30,000.00 - ₹40,000.00 per year

Experience

- industrial : 2 years (Preferred)

Work Location: In person

📌 QA Executive (Mumbai)
🏢 Mumbai Biocluster
📍 Mumbai

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