Data Reviewer

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!

• Medical, Dental, Vision Benefits
• Health Savings Account (HSA), Flexible Spending Account (FSA)
• Prescription Drug Coverage
• Telehealth and Behavior Health Services
• Income Protection – Short Term and Long Term Disability Benefits
• Retirement Benefits - 401k Company Match on Day One (100% vesting immediately)
• Group Life Insurance
• Wellness Programs
• Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods!

Sun Pharma Vision: Reaching People And Touching Lives Globally As A Leading Provider Of Valued Medicines
Sun Pharmaceutical Industries Ltd. (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.
Our Code of Conduct
Our Global Code of Conduct governs every aspect of our operations. Sun Pharma is a family of thousands of people, working across many countries, speaking multiple languages, and all united, with one common purpose: to make good health accessible and affordable to local communities and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health. The way we work every day is important to us.
DOWNLOAD OUR CODE OF CONDUCT
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. He/ she shall be responsible to review each pre-submission application by using exhaustive audit checklist to ensure Data Integrity, Reliability, Accuracy, and Traceability.

• 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.

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.
• Minimum 5-7 years of experience in a pharmaceutical company within GMP environment in Quality Control department.
• 2-3 years of Quality Assurance exposure in Pharmaceutical industry is preferable, involving review of manufacturing/ packaging batch records and investigations
• Knowledge in and review of, but not limited to: Laboratory test procedures, cGMP requirements, cGLP, 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).

Location: 14 Terminal Road

Job Type: Full-time

Schedule:

• Monday to Friday

Work Location: One location