Senior Executive – Quality Assurance (Capsule Division) - JG

Experience Required:

Qualification:

Work schedule:

About The Organization

• Ensure manufacturing practices align with cGMP and GLP standards
• Manage QMS activities: change control, validations, stability, qualifications, APQR, risk assessments
• Coordinate applications for regulatory and statutory approvals (such as environmental clearances and export-related documentation)
• Organize and document internal/external audits (ISO, GMP+, FDA, and other relevant regulatory bodies)
• Evaluate and approve suppliers for RM, PM, testing labs, and service providers
• Assist in customer complaint analysis and reporting
• Investigate incidents, deviations, OOS; implement corrective actions
• Review operator availability and allocate tasks
• Maintain and review BMR documents; guide relevant updates
• Review and manage label artwork
  

Technical

• Analytical thinking and trend spotting
• Strong report writing and problem-solving skills
• Sound knowledge of GMP and GDP
• Proficient English communication (verbal & written)
  

Behavioral

• Quality and service orientation
• Consistent delivery and time management
• Customer-centric mindset
• Cross-functional collaboration
  

• Reports to: Plant Head
• Manages: 2 Assistant Officers – QA
  

• Tarapur MIDC, Boisar (1.5 hrs from Borivali by train or road)
• Direct suburban trains from Churchgate to Boisar
• Subsidized housing for bachelors and families
• Relocation allowance available
  

• Be part of a niche, globally connected organization
• Work at the head office with international exposure
• Enjoy a small-company culture with MNC-level professionalism
• Participate in employee engagement programs and celebrations
• Medical insurance for immediate family
• Housing support for outstation candidates