Senior Manager - Compliance Lead

SUN PHARMA; Baksa; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Sun Pharma is seeking a Sr. Manager (Compliance Lead) to spearhead regulatory inspections, internal audits, and CAPA processes at the Baksa site.

The role focuses on ensuring top-tier compliance across manufacturing operations and supplier qualification for API and critical materials. Responsibilities include coordinating with external parties and internal teams, driving CAPAs, and leading the self-inspection program to identify and mitigate compliance risks, with regular updates to senior

Qualifications

• Regulatory compliance experience in pharma manufacturing.
• Experience leading internal audits and regulatory inspections.
• CAPA initiation, tracking and closure to address observations.

Responsibilities

• Lead inspection processes at the plant with external parties and internal teams.
• Lead internal audits/self-inspections and drive corrective/preventive actions.
• Qualify and qualify suppliers for API/RM/PM and critical consumables.
• Coordinate CAPA efforts with Global Quality Management and site teams.
• Provide training to team members to ensure compliant operations.

Skills

Regulatory compliance

Internal audit

CAPA management

Supplier qualification

Audit coordination

Education

MSc? / M.Pharm

B.Pharm / M.Pharm

Job description

Job Description:

Job Title: Sr. Manager (Compliance Lead)

Business Unit: Sun Global Operations

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