Executive

Job Title:

Executive

Business Unit:

Global Quality and Compliance

Job Grade

G12A

Location :

Baddi

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:

• Review and approve User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents for:
• Facility and utility systems (HVAC, water systems, compressed air, etc.)
• Manufacturing and laboratory equipment
• Process validation and cleaning validation activities
• Ensure validation activities are conducted in compliance with cGMP and regulatory expectations.
• Coordinate with cross-functional teams (Engineering, Production, QC, etc.) for timely execution of validation projects.
• Quality Management System (QMS):

• Participate in and support Deviation Management, Change Control, CAPA, and Risk Assessments.
• Ensure documentation practices align with ALCOA+ principles.
• Maintain validation master plans and ensure periodic review and updates.

• Investigations & Compliance:

• Lead or support root cause investigations for validation-related deviations or failures.
• Apply structured problem-solving tools (e.g., 5 Whys, Fishbone, FMEA) to identify and mitigate risks.

• Support internal and external audits (USFDA, MHRA, WHO, etc.) by providing validation documentation and justifications.
• In-depth knowledge of cGMP, ICH Q8–Q10, FDA, EMA, and WHO guidelines.
• Strong experience in reviewing and approving IQ/OQ/PQ protocols and reports.
• Familiarity with electronic QMS platforms (e.g., TrackWise) is an advantage.

Travel Estimate

Job Requirements

Educational Qualification

B. Pharma

Experience

Tenure: 5-8 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).