Senior Manager - Compliance Lead (Sterile)

Job Title:

Sr. Manager (Compliance Lead)

Business Unit:

Global Quality & Compliance

Job Grade

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:

• Lead inspection process in the plant

 

• • Coordinate with external parties/ internal CFT/ Quality Head and Site Head to organize regulatory inspections/ customer/ certification body audits at site.
  • Will be responsible to update Senior Management on the audit process and outcome on a timely basis as per SOP
  • Will be responsible for timely response to the observations generated from the inspection, initiation of CAPAs in order to address the observations, follow-up with the responsible person/ department for completion of the actions within due date, review of CAPA/ action item closure for adequacy and involve in effectiveness check
  • Frequent shop-floor visit in order to verify the compliance status, identifying and highlighting possibilities of repeat observation and potential noncompliance that can lead to observation during inspections
  • 483 observations/ other inspectional observations- perform gap assessment and implement CAPA in case of any gaps.

 

• Lead Internal audit/ Self Inspection

 

• • Ensure effective self-inspection process is in place to proactively detect potential compliance risk and mitigate through effective CAPA.
  • Plan, coordinate and ensure compliance.
  • Driving system and facility improvements based on the gaps identified during self-inspection.

 

• Supplier Management
  • Responsible for qualification of suppliers related to API/RM/PM
  • Responsible for qualification of suppliers for critical consumables and items used in aseptic areas.
  • Responsible for qualification of other service providors
  • Coordinate for risk assessments in case of any noncompliance observed with respect to suppliers

 

• Global Actions/ CAPAs
  • Coordinate with Global Quality Management with respect to assessment and remediation of the gaps identified in other facilities of Sun or other organizations.
  •  
• Others: Training of team members in order to enable them to perform their jobs in proper way.

 

 

Travel Estimate

Nil

Job Requirements

Educational Qualification: MSc/ M. Pharm

B.Pharm / M.Pharm

Experience: 14 – 15 Years

Tenure: Ovearall experience of atleast 15 to 16 Yrs and >3 years of experience as Compliance Lead/ QMS Lead

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).