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SUN PHARMA · 9 hours ago

Data Reviewer, Office Data Reliability

Brunswick, NY

Full-time

Onsite

Senior Level

5+ years exp

SUN PHARMA is a leading pharmaceutical company, and they are seeking a Data Reviewer for their Office of Data Reliability. The role involves critical review of pre-submission applications for regulatory submission to the US FDA, ensuring data integrity and compliance with established procedures.

Biotechnology

H1B Sponsor Likely

Responsibilities

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

Qualification

CGMP complianceQuality Control experienceAnalytical R&D experienceMS Office proficiencyProject management skillsProfessional conductEnglish proficiencyInterpersonal communicationTeam playerProblem solving skills

Required

Minimum Bachelor of Science (B.S.) in Chemistry, Pharmacy, Biochemistry or related field

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)

Minimum 5 years of experience in a pharmaceutical company within a cGMP environment in Quality Control and/or Analytical R&D department is required

Preferred

A Master of Science (M.S.) in Chemistry, Pharmacy, Biochemistry or related field is desirable

Minimum 2 years of Quality Assurance exposure in Pharmaceutical industry, involving review of manufacturing/ packaging batch records and investigations is desirable

Company

SUN PHARMA

Glassdoor3.8

Sun Pharma is the world's fourth-largest speciality generic pharmaceutical company and No. 1 in India.

Founded in 1983

Mumbai, Maharashtra, IND

10001+ employees

http://www.sunpharma.com

H1B Sponsorship

SUN PHARMA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (15)

2024 (10)

2023 (6)

2022 (12)

2021 (9)

2020 (11)