Title:  Compliance Associate II

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. 

Job Summary:

The Associate II, Compliance is responsible for conducting activities to ensure site compliance to cGMP regulations as well as internal quality procedures.  The Associate II Compliance is responsible for managing and conducting Investigations, Product Quality Complaints, CAPAs, Deviations and Change Controls. Ensures adherence to SOPs and policies. Provide assistance during regulatory, corporate and internal audits.

Schedule: Monday - Friday, 9:00am-5:30pm

Area Of Responsibility:

• Maintaining the Global Documents implementation tracker and update the tracker on timely basis and communicate with the Global corporate team.
• Perform gap assessment and manage the implementation of global procedures at site by coordinating with cross-functional team
• Assessing and reviewing the site change controls in Trackwise and conducting change control review board meeting as applicable
• Reviews and approves Action Items, CAPA and Global CAPA in Trackwise and monitors the effectiveness of CAPA.
•  Conduct and Lead the annual cGMP training program for the site
• Initial Acknowledgement and classification of the site deviations in trackwise on timely manner.
• Assists in ensuring FDA Readiness Plan for the facility. Provides support for all regulatory audits, internal/external inspections, and other audits.
• Responsible for follow-ups on all related Operational findings from FDA, other regulatory bodies, internal audits, etc.
• Participates and conducts mock inspections to prepare the facility for audits and assesses gaps in the system; review documents for compliance to current regulations and cGMPs.
• Identifies compliance issues and supports the implementation changes for constant improvements. 
• Supports adherence to SOPs and policies and assists in ensuring that procedures reflect current practice. Create new SOP’s and revise the existing SOP’s as applicable.
• Reviews and approves Qualification Protocols and Reports for equipment and product validations/verifications.

Work Conditions: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job in an office, lab, or manufacturing environment. The noise level in the work environment is usually moderate.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear. The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bend.
• Must be capable of bending and lifting, moving and/or carrying up to approximately 20 pounds.
• Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
• Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Travel Estimate: Up to 5%

Education and Job Qualification:

• Minimum of Bachelor’s degree.
• Demonstrated ability and knowledge of QMS and driving investigations to completion.

• Thorough understanding of GMPs.
• Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise or similar QMS, LMS (Learning Management System) etc.
• Strong knowledge of project management principles, practices, techniques and tools.
• Excellent interpersonal and communication, both written and verbal, skills.
• Excellent organizational and time management skills; must be able to prioritize and manage multiple assignments simultaneously while working independently or with others as needed.
• A self-starter with a hands-on approach and a can-do attitude.
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Experience:

• Minimum five (5) years of experience within the pharmaceutical industry in quality function role.
• Experience working in an international multicultural matrix organization.

Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees 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 the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

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).