QA Data Reviewer

Company: Sun Pharmaceuticals, Inc
Location: New Brunswick
Posted on: June 18, 2022

Job Description:

QA Data ReviewerLocationNJ, New BrunswickJob CategoryQuality AssuranceEmployment DurationFull timeCOME 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 novation. It represents our promise to all stakeholders including patients, physicians, and employees.Our Code of ConductOur 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 (om/wp-content/uploads/2021/01/SPIL-Global-Code-of-Conduct/_revised-effective-1st-April-2018-2.pdf)
Performs critical in-depth review of all scientific data for Quality Control laboratory documents under general supervision.
Under the direction of QA management, this individual:
+ Performs critical in-depth review of all scientific data for Quality Control laboratory documents (including, but not limited to review of raw data of in-process, API/Excipients, Finished Products, Stability, Cleaning Verification, Instrument calibration records, Contract laboratory results notebooks, reports, and materials for ANDA submissions) for completeness, integrity and accuracy.
+ Demonstrates a thorough knowledge of approved SOPs, compendia (USP, BP, and EP), ICH, FDA and other regulatory guidances.
+ Ensures that all documents are in compliance with cGMPs and the site operating procedures under the direction of QA management.
+ Supports systems to ensure the successful completion of Departmental goals and objectives.
Qualifications
+ Minimum of a Bachelors.
+ Minimum of six (6) years of experience in a pharmaceutical environment with a minimum four (4) years of experience in chromatography (e.g. HPLC with empower data acquisition software, GC, FTIR, UV and wet chemistry).
+ Knowledge of pharmaceutical analysis.
+ Ability to review laboratory records with minimal supervision within the framework of cGMP/GLP for analytical laboratories.
+ Good understanding of EHS and OSHA safety guidelines.
+ Knowledge of USP, ICH, FDA, and DEA regulations.
+ Knowledge of the operating principles of HPLC, UV, FTIR, GLC, and Malvern particle size analyzers.
+ Demonstrated excellent communication: verbal, written and presentation skills.
+ 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).

Keywords: Sun Pharmaceuticals, Inc, New Brunswick , QA Data Reviewer, Other , New Brunswick, New Jersey