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- Maintain controlled-document registers and ensure obsolete documents are appropriately withdrawn.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