Senior Manager - Validation Lead

Job Title:

Validation Lead

Business Unit:

Sun Global Operations

Job Grade

Sr. Manager 1 (G9A)

Location :

Baska

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:

• Plan and monitor the activities related to quality engineering section.
• Plan and monitor the activities related to new quality projects.
• Review and approval of annual and monthly re-qualification schedule and ensuring timely updation of schedule.
• Day to day Inter-Departmental communication for timely completion of qualification / re-requalification activities.
• Ensuring timely execution and closure of qualification and re-qualification protocols of equipment, personnel, utilities, etc.
• Review and approval of URS, DQ, SAT, FAT, IQ, OQ and PQ qualification / re-qualification protocols, reports and summaries.
• Review and approval of qualification master plan.
• Review of breakdown maintenance memo for equipment, utility, etc.
• Review and approval of deviation qualification/ re-qualification.
• Review and approval of UPD, PD, CAPA and change control etc. related to equipment and QE department.
• Preparation of monthly and quarter CQ report for QE department.
• Review and approval QA SOPs related to QE and ensure effective implementation.
• To perform internal and external audit as per required by site QA team.
• Ensuring timely submission of documents and responses required from RA as well as internal and external audit observation related to QE department.
• To identify training need for Quality Engineering individual and provide training.
• Review and approval of all qualification / re-qualification and quality management system related documents.

Travel Estimate

Job Requirements

Educational Qualification

B. Pharm. / M. Pharm.

Experience

Tenure:  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).