Position/Job Title
General Manager
Department
Quality Assurance
Reporting To
VP Corporate Quality Assurance
Location
Satara
Years Of Experience
15-25 Years
Dosage Form
Solid Oral / Liquid, Nasal is preferred
Job Responsibilities/Deliverables
Quality Management System (QMS):
- Develop, implement, and maintain a robust QMS that aligns with global regulatory requirements (FDA, EMA, WHO) and industry standards.
- Ensure that all processes, documentation, and practices are in compliance with current GMP, GDP, and other applicable regulations.
Compliance And Audits
- Lead and manage regulatory inspections and audits (internal and external) and ensure timely resolution of audit findings.
- Conduct regular internal audits and quality reviews to ensure adherence to quality standards and regulatory requirements.
Team Leadership And Development
- Build and mentor a high-performing QA team by setting clear objectives, providing training, and fostering a culture of accountability and quality.
- Conduct performance appraisals and provide coaching to develop technical expertise and leadership skills within the team.
Risk Management
- Develop risk assessment and management strategies to identify potential quality issues proactively.
- Implement CAPA (Corrective and Preventive Actions) for deviations and ensure effective tracking and closure.
Quality Operations
- Oversee quality operations, including batch record review, product release, deviations management, and OOS (Out of Specification) investigations and market complaints.
- Ensure that quality control (QC) activities are effectively integrated with QA to meet product specifications and quality standards.
Process Improvement
- Drive continuous improvement initiatives to optimize quality processes, reduce non-conformances, and improve operational efficiencies.
- Monitor industry trends and regulatory changes, updating procedures and practices as necessary.
Stakeholder Management
- Collaborate with production, regulatory affairs, and other departments to address quality-related issues and support product development and lifecycle management.
- Serve as the primary point of contact for quality-related matters with regulatory authorities and key external stakeholder
Qualifications & Pre-Requisites
Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related field. Advanced degrees (e.g., MBA, PhD) are advantageous.
Experience: Minimum of 10-15 years of experience in the pharmaceutical industry, with at least 5 years in a senior QA leadership role.
Deep understanding of regulatory requirements (FDA, EMA, ICH) and GMP/GLP standards. Familiarity with sterile manufacturing, aseptic processing, and biotechnology is beneficial.
Strong leadership and team management capabilities.
Exceptional analytical and problem-solving skills.
Excellent communication and interpersonal skills.
Ability to make critical decisions under pressure and manage complex quality challenges
Additional Notes
Role is expected to work in shifts as when required
