Location: New Brunswick,NJ, USA
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 QC Compliance Section Head leads and manages compliance related activities in Quality Control, focusing on out of specification (OOS), out of trend (OOT), Laboratory Events, CAPAs, and change controls. Responsible to manage laboratory test methods and specifications, revisions of operational procedures, and driving implementation of global documents. Responsible for meteorology activities in QC lab. Determines Quality Control KPI's and metrics and identifies potential process improvements. Ensures inspection readiness and is able to respond to any audit observations.
* Lead and manage compliance related activities in Quality Control including, but not limited to deviations (i.e. OOS, OOT, and Laboratory Events), CAPAs, and change controls.
* This is a supervisory position with direct reports; therefore, this position will establish goals and objectives, prepare performance appraisals, monitor/review work product and coach/mentor direct reports.
* Provide technical support, apply expertise, and critical thinking to help resolve technical and compliance issues.
* Monitor and ensure timely closure of all laboratory related Quality Management System records.
* Review and approve new and revised test methods and specifications.
* Review and approve laboratory operational procedures, training materials, and procedures for various systems.
* Drive implementation of global documents related to Quality Control functions.
* Participate in and reviews/approves laboratory investigations.
* Represents Quality Control at cross-functional meetings.
* Lead QC metrology program of QC lab that includes instrument IQ/OP/PQ/Maintenance etc.
* Establish, determine, and drive the improvement in established KPI's / metrics for the Quality Control laboratory.
* Trend OOS, OOT, and Laboratory Events to identify process improvements.
* Assist in ensuring inspection readiness.
* Assist in responses to any internal audit, corporate audit, or regulatory audit observations involving Quality Control.
* This is supervisory position with direct reports; therefore, this position will establish goals and objectives, prepare performance appraisals, monitor/review work product and coach/mentor direct reports
Qualifications
* Minimum BS or equivalent degree in Chemistry or related filed. MS/Ph.D. preferred.
* Minimum of ten (10) years of experience in pharmaceutical laboratory.
* Experience in pharmaceutical QC laboratory with management experience.
* Must be familiar with cGMP/GLP practices for analytical laboratories, and with ICH and FDA guidance.
* Excellent knowledge of HPLC, UPLC, GC, UV-Vis, Dissolution, FTIR, LC-MS, ICP-MS and other analytical instruments. Excellent working knowledge of USP, EP, ICH and FDA guidelines
* The ability to organize complex work assignments and oversee analysts and staff to complete tasks andprojects on time.
* Demonstrated technical project management experience to develop project goals, deliverables, and timelines.
* Well versed with Microsoft Office. Must have laboratory investigation technique and writing skills.
* Knowledge of relevant compendia, chemical assays and general lab equipment.
* Ability developing project goals, deliverables and timelines.
* Demonstrated excellent communication: verbal, written and presentation skills.
* A self-starter with a hands-on approach and a can-do attitude.
* A team building champion driving innovative cross functional synergies.
* Excellent project management and problem solving skills
* The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to GlobalCEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
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