Associate II, Compliance

Sun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

We are seeking a highly motivated and detail-oriented Compliance Associate II to support and strengthen our Quality Management System (QMS) and site compliance programs. This role plays a critical part in maintaining regulatory compliance, driving quality system effectiveness, supporting inspection readiness, and ensuring adherence to cGMP requirements. As a key member of the Quality organization, you will independently manage quality system processes, including Deviation Management, Change Control, and Cleaning Validation, while partnering with cross-functional teams to promote continuous improvement and inspection readiness across the site.

• Independently manage and perform preliminary assessments for deviations within Track Wise.
• Independently review and manage change controls and facilitate Change Review Board (CRB) meetings to ensure effective evaluation and implementation of proposed changes.
• Monitor deviation and change control life cycles to ensure timely investigations, extensions, approvals, and closures.
• Collaborate with cross-functional teams to drive quality events to completion and maintain compliance with established procedures.
• Ensure compliance with Data Integrity (ALCOA+) principles across investigations, validation documentation, and GMP records.

• Collect, analyze, trend, and report quality metrics related to deviations and change controls on a monthly, quarterly, and annual basis.
• Identify recurring compliance risks, emerging trends, and improvement opportunities.
• Escalate significant findings and recommend corrective and preventive actions.
• Prepare quality summaries and presentations for Quality Management Reviews (QMRs) and leadership meetings.

• Maintain and oversee the site's Cleaning Validation Program.
• Develop and maintain the Cleaning Validation Master Plan (CVMP).
• Support the lifecycle management of cleaning validation activities, including:
  • Initial validation
  • Periodic review
  • Revalidation strategies
  • Continued verification activities
• Design, review, and approve cleaning validation protocols and reports.
• Conduct risk assessments for cleaning processes and validation activities.
• Evaluate:
  • Worst-case product selection
  • Sampling strategies (swab and rinse)
  • Analytical methods
  • Acceptance criteria
• Ensure appropriate establishment, justification, and documentation of MACO (Maximum Allowable Carryover) limits.
• Assess validation impacts resulting from deviations, investigations, and process changes.

• Support the site's FDA and regulatory inspection readiness programs.
• Participate in mock inspections, compliance assessments, and gap analyses.
• Provide support during:
  • FDA inspections
  • Customer audits
  • Internal audits
  • Corporate audits
• Assist with audit coordination, documentation requests, and back- room support activities.
• Support investigation reviews and compliance-related projects as needed.

This position operates in a combination of office, laboratory, and manufacturing environments. The role requires frequent interaction with Quality, Manufacturing, Validation, and Regulatory teams to support site compliance initiatives.

• Manufacturing and production areas
• Laboratories and support areas
• Moderate noise levels
• Periodic use of personal protective equipment (PPE)

• Ability to stand, walk, sit, bend, stoop, kneel, crouch, crawl, and reach as needed.
• Ability to lift and carry up to 20 pounds.
• Ability to navigate office, laboratory, warehouse, and…