Validation Manager

Sun Pharmaceutical Industries, Inc.; Kamrup Metropolitan; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Sun Pharma in India seeks a senior validation professional to lead the Validation department and drive the strategy for equipment, instruments, systems, utilities, manufacturing processes, packing and lab equipment.

Educational requirement is B Pharma/M Pharma with 12–15 years of experience in pharmaceutical validation. The role focuses on GMP/QMS compliance, audits, CAPA, deviation handling and enabling training for the team.

Qualifications

• B Pharma/M Pharma is required.
• 12–15 years of experience in pharmaceutical validation.
• Experience in planning, reviewing and implementing qualification protocols for equipment, instruments, systems, utilities, manufacturing processes, packing and laboratory equipment.

Responsibilities

• Lead the Validation department and drive the validation strategy.
• Plan, review and implement qualification protocols and documents.
• Support audits and ensure compliance with GMP and Quality Management System (QMS).
• Provide training to personnel involved in qualification and validation activities.

Skills

Validation leadership

GxP

Documentation

Audit readiness

Leadership

Education

B Pharma/M Pharma

Tools

TrackWise

Job description

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At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Key responsibilities:

• To take the lead of Validation department.
• To plan, review and implement the validation strategy
• Planning and preparation of qualification protocols and documents for equipment, instruments, systems, including of utilities, manufacturing process, packing and laboratory equipment
• Review , execution and compilation of qualification protocols and documents for equipment, instruments, systems, including of utilities, manufacturing process, packing and laboratory equipment
• To support and involve in audit related to Validation
• Preparation / Review of yearly and add-on schedule for Periodic Performance Verification-Performance Testing (PPV-PTS).
• Preparation / Review of yearly and add-on schedule for Periodic Performance Verification-Support Program Review (PPV-SPR).
• Follow and ensure compliance of validation SOPs, policy documents and written procedures
• Follow and ensure the current Good Manufacturing Practices as per applicable SOPs
• Follow and comply the Quality Management System, i.e., Handling of deviation, Investigation, CAPA and Change Controls
• Evaluation, implementation and closure of action items in Trackwise.
• Participation in Quality Improvement Projects
• Provide training to the personnel involved in qualification and validation activities as & when required.
• Arrangement, Tracking, Preparation, Review & compliance for the document required for Inspection at site.
• Co-ordination with CFT for smooth functioning of qualification activity
• Handling of team & department
• Any other responsibility that may be assigned from time to time by HOD.

Job Requirements

Educational Qualification

B Pharma/M Pharma

Experience

Tenure : : 12 to 15 years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).