Title:  Validation Chemist

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 Validation Chemist is responsible for developing and executing validation protocols for equipment, facilities, processes, and cleaning procedures to ensure compliance with cGMP standards. This role involves planning and scheduling validation activities, conducting studies, and preparing comprehensive reports. The chemist supports quality assurance by reviewing batch records, monitoring QMS records, and ensuring audit readiness. They serve as a key resource for quality-related information across departments and contribute to continuous improvement initiatives by evaluating and enhancing SOPs and procedures. Additional responsibilities include assisting with audits, maintaining QC method training programs, completing Annual Product Quality Reviews (APQRs), and supporting compliance.

Responsibilities:

• Develops validation protocols for equipment, facilities, processes, and cleaning procedures.
• Plans and schedules validation activities.
• Performs validation studies per schedule and written protocols.
• Accurately accumulates, documents, and communicates data.
• Prepares and submits validation final reports.
• Audit and ensure the site is always audit ready by ensuring compliance to cGMP, SReview and approve batch records as needed to ensure quality compliance.
• Monitor and ensure on-time closures of all QMS records daily.
• Review and approve orders as they ship to ensure quality compliance.
• Available to be the first source of quality information needed by all CCI departments.
• Recognize, recommend, evaluate, and implements steps to improve procedures, SOP’s, and products.
• Complete APQR’s as needed
• Monitor and update QC method training program and method table of contents as needed.
• Assist in all customer, corporate, and regulatory audits as needed.
• Other activities as instructed from time to time.

Qualifications:  

• B.S. degree in Chemistry or related field. 
• 1-2 years of experience in a GMP environment preferred but not required. 
• Proficient in the use of Microsoft suite/365.
• Must work effectively both as an individual and as a team member.

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.