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Capsule / Pharma Manufacturing logo
Senior Executive – QA
Capsule / Pharma Manufacturing
Capsule / Pharma Manufacturing's logo

Senior Executive – QA

at Capsule / Pharma Manufacturing

8 - 14 yrs
₹10L - ₹16L / yr
Boisar
Skills
Quality control
GMP
GLP
QMS
Documentation
Risk assessment
GDP

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:

  1. Maintain and improve QMS, GMP and GLP compliance across the plant.
  2. Handle QMS functions including change control, validations, stability studies, equipment qualifications, APQR, and risk assessments.
  3. Manage documentation and coordination of regulatory applications such as AHC to AQCS, EIA, and related compliance.
  4. Plan and conduct internal & external audits for standards such as ISO, GMP+, FDA, EIA, Capexil etc., and ensure documentation readiness.
  5. Evaluate and approve suppliers for raw materials, packaging materials, testing labs, and service providers.
  6. Support in customer complaint investigation and CAPA implementation.
  7. Conduct incident, deviation, and OOS investigations and ensure corrective & preventive actions.
  8. Review and maintain Batch Manufacturing Records (BMRs) and suggest improvements.
  9. Manage label artwork review and control processes.
  10. 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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