Sun Pharma is the worlds 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. **Job Summary:** 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. **What You'll Do:** **Quality Systems Management** + Independently manage and perform preliminary assessments for deviations within TrackWise. + 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 lifecycles 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. **Quality Metrics & Continuous Improvement** + 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. **Cleaning Validation Program Management** + 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. **Audit & Inspection Readiness** + 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. **Work Environment:** 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. The work environment may include: + Manufacturing and production areas + Laboratories and support areas + Moderate noise levels + Periodic use of personal protective equipment (PPE) **Physical Requirements:** + 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 manufacturing environments. + Must be able to wear required PPE, including respirators, safety glasses, and safety shoes. Travel: Up to 5% **What You Bring:** **Education** + Bachelor's degree required. **Technical Knowledge & Skills** + Demonstrated experience with Quality Management Systems (QMS) and quality event management. + Strong knowledge of cGMP regulations, quality systems, and pharmaceutical compliance requirements. + Experience driving investigations, deviations, and change controls to closure. + Working knowledge of: + TrackWise or similar QMS platforms + Learning Management Systems (LM