Senior Executive – QA
at Capsule / Pharma Manufacturing
Position: Senior Executive – QA (Capsule / Pharma Manufacturing)
About Company:
A growing organization engaged in manufacturing high-quality empty gelatin capsules and laboratory-scale pharma machines for global markets. The work environment combines the personal culture of a small unit with the process discipline of an international organization, offering strong career development, supportive leadership, and employee-focused benefits.
Location:
- Tarapur MIDC, Boisar, Dist. Palghar, Maharashtra
- Candidates from nearby areas preferred
- Company Accommodation Provided (for Bachelors / Family)
Qualification:
- B.Pharm OR B.Sc / M.Sc (Chemistry / Microbiology)
Experience:
- Minimum 8+ years in Quality Assurance
- Experience in Pharmaceutical / Food Processing / Cosmetics / Chemical manufacturing industry
- Knowledge of GMP, GLP, QMS activities required
Work Schedule & Timings:
- Friday – Fixed Weekly Off
- Alternate Saturdays Off
- Work Hours: 9:00 AM to 5:30 PM
Notice Period:
- Up to 30 Days acceptable
- Buyout Option is available
Key Responsibilities:
- Maintain and improve QMS, GMP and GLP compliance across the plant.
- Handle QMS functions including change control, validations, stability studies, equipment qualifications, APQR, and risk assessments.
- Manage documentation and coordination of regulatory applications such as AHC to AQCS, EIA, and related compliance.
- Plan and conduct internal & external audits for standards such as ISO, GMP+, FDA, EIA, Capexil etc., and ensure documentation readiness.
- Evaluate and approve suppliers for raw materials, packaging materials, testing labs, and service providers.
- Support in customer complaint investigation and CAPA implementation.
- Conduct incident, deviation, and OOS investigations and ensure corrective & preventive actions.
- Review and maintain Batch Manufacturing Records (BMRs) and suggest improvements.
- Manage label artwork review and control processes.
- Oversee daily operator allocation and resource availability.
Skills & Competencies:
Technical:
- Strong analytical and problem-solving skills
- Report writing and documentation skills
- Good understanding of GMP, GDP, and regulatory standards
- Good English communication (written & verbal)
Behavioural:
- Quality & service orientation
- Strong planning, prioritization, and time management skills
- Ability to work cross-functionally and collaborate effectively
Reporting Structure:
- Reports to: Plant Head
- Team Handling: 2 QA Assistants
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