QA Executive

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• Maintain controlled-document registers and ensure obsolete documents are appropriately withdrawn.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
• Opportunity 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