Senior Executive – QA

About Company

• Tarapur MIDC, Boisar, Dist. Palghar, Maharashtra
• Candidates from nearby areas preferred. Relocation also preffered.
• 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.
  

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