Kapoor Glass India Pvt Ltd is one of India's largest manufacturer of Glass Ampoules, Vials and Cartridges. The company produces 1.5 million pcs each day and exports over 90% to over 35 countries.
Kapoor Glass has 3 dedicated units located at Panvel Navi Mumbai and its strength lies in internal design and development of cutting edge, state of the art equipment to meet the highest quality and performance standards.
Job Summary
The Senior QA Executive is responsible for ensuring that all manufacturing, testing, and release activities for glass ampoules, vials, and cartridges comply with applicable regulatory standards, internal quality systems, and customer requirements. This role supports the QA Manager in maintaining GMP compliance, driving continuous improvement, and ensuring product quality and integrity.
Key ResponsibilitiesQuality Systems & Compliance
- Ensure compliance with current GMP, regulatory guidelines, and internal quality standards.
- Support implementation and maintenance of Quality Management Systems (QMS).
- Review and approve SOPs, specifications, protocols, and reports.
- Participate in regulatory inspections and customer audits; support audit readiness activities.
Batch Review & Release
- Review Batch Manufacturing Records (BMR) prior to batch release and despatch
- Perform line clearance checks and in-process QA oversight.
- Support final product release in coordination with QA Manager.
Documentation & Control
- Manage document control systems including SOP issuance, revision, and archival.
- Ensure proper data integrity practices
- Review and approve logbooks, calibration records, and validation documentation.
Deviation, CAPA & Change Control
- Investigate deviations, non-conformances, and customer complaints.
- Lead root cause analysis and ensure timely closure of CAPAs.
- Review and approve change control requests and assess impact on product quality.
Validation & Qualification
- Support equipment qualification (IQ/OQ/PQ) and process validation activities.
- Review validation protocols and reports for manufacturing and inspection systems.
- Ensure periodic revalidation as required.
In-Process Quality Assurance
- Monitor critical process parameters during forming, annealing, inspection, and packaging.
- Conduct shop-floor QA activities including line audits and GMP checks.
- Ensure adherence to environmental and cleanliness requirements.
Supplier & Raw Material Quality
- Support vendor qualification and performance monitoring.
- Review incoming material COAs and ensure compliance with specifications.
Continuous Improvement
- Identify opportunities for process improvement and defect reduction.
- Track and analyze quality metrics (rejections, deviations, complaints).
- Drive initiatives to enhance product quality and operational efficiency.
Required Qualifications
- Minimum Bachelor’s degree in Pharmacy, Chemistry, or related science field.
- 2-4 years of experience in QA within pharmaceutical manufacturing or pharma packaging (preferably glass ampoules/vials/cartridges).
- Strong knowledge of GMP, ISO standards, and regulatory expectations.
Key Skills & Competencies
- Solid understanding of glass forming and inspection processes (visual inspection, dimensional checks, cosmetic defects).
- Experience with deviation handling, CAPA, and audits.
- Strong documentation and review skills.
- Attention to detail and data integrity mindset.
- Good communication and cross-functional coordination abilities.
Preferred Experience
- Exposure to regulatory/customer audits
- Experience in sterile or primary packaging environments.
- Familiarity with automated inspection systems and defect classification.
KPIs / Performance Indicators
- Timely batch release and documentation review
- Closure time for deviations and CAPAs
- Audit observations and compliance status
- Reduction in defect rates and customer complaints
- Training effectiveness and compliance adherence
Job Type: Full-time
Pay: ₹350,000.00 - ₹500,000.00 per year
Benefits:
- Paid sick time
- Paid time off
- Provident Fund
Ability to commute/relocate:
- Panvel, Maharashtra: Reliably commute or planning to relocate before starting work (Required)
Application Question(s):
- Lives in Navi Mumbai / Panvel area?
Experience:
- total work: 2 years (Required)
Language:
Work Location: In person
