Job Description

Sun Pharmaceutical Industries Inc. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility. Integrity. Passion. Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.

Job Overview:

The Data Reviewer, Office of Data Reliability (ODR) is accountable for critical review of pre-submission applications ready for regulatory submission to the US FDA. Responsibilities include the review of assigned pre-submission applications by using department SOPs and exhaustive audit checklists to ensure Data Integrity, Reliability, Accuracy, and Traceability of any submitted data.

Responsibilities:

• MUST HAVE PRIOR EXPERIENCE WITHIN PHARMA AND/OR FOOD
• Ensures compliance with cGMP/cGLP and good documentation procedure during the review process
• Audits regulatory pre-submission documents from the manufacturing and quality units within the purview of ODR checklist
• Communicates any audit comments/ observations/ findings to respective stakeholders and assesses acceptability/ appropriateness of responses
• Informs the manager/s and Chief Data Reliability Officer immediately of any critical data integrity issues or data irregularity
• Reports all audit finding in the ODR audit worksheets and highlight noteworthy/ major/ critical observations on CDRO certifications
• Completes the audit tasks within the specified timeframe without compromising the quality of the audit and archives all documents in a closed electronic system
• Collates audit findings in the audit comments log
• Performs any other responsibilities which are required as assigned by the manager/s depending on departmental needs
• Completes all training requirements as per Learning Management System (LMS) and as per Safety
• Adheres to the Safety and Health Program and associated plans.

Candidate Qualifications:

• Minimum Bachelor of Science (B.S.) in Chemistry, Pharmacy, Biochemistry or related field. A Master of Science (M.S.) in Chemistry, Pharmacy, Biochemistry or related field is desirable.
• Knowledge in and review of, but not limited to, the following: Laboratory test procedures, cGMP/cGLP/cGDP requirements, ICH/US FDA guidelines, raw material analyses, method validation guidelines, analytical method transfers, finished products and stability testing procedures; standard operating procedures, general procedures, test procedures, validation protocols; manufacturing and packaging batch records, excipients COAs, packaging components COAs, manufacturing reports, scale-up reports, product development reports; Quality overall summaries, executive summaries
• Proficient in MS Office applications (Word, Excel)
• Ability to monitor, coordinate and prioritize work in an effective and efficient manner, with capacity to manage simultaneous projects within a set timeline; ability to continuously make an assessment of the work load and suggest any support required on need basis
• Must be a self-motivated, proactive team player with positive interaction with colleagues and stakeholders to ensure work ethics, teamwork, and discipline.
• Conduct oneself in a professional manner in alignment with corporate values.
• Ability to work and interact successfully in a global, diverse and dynamic environment.
• Demonstrates excellent interpersonal communication skills: verbal, written and presentation skills.
• Excellent project management and problem solving skills

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 Necessary:

• Minimum 5 years of experience in a pharmaceutical company within a cGMP environment in Quality Control and/or Analytical R&D department is required.
• Minimum 2 years of Quality Assurance exposure in Pharmaceutical industry, involving review of manufacturing/ packaging batch records and investigations is desirable
• YOU MUST HAVE FDA PRESUBMISSIONS EXPERIENCE
• MUST HAVE PHARMA/FOOD MANUFACTURING AND DISTRIBUTION EXPERIENCE
• MUST HAVE QA DATA REVIEW EXPERIENCE

Sun Pharmaceutical Industries