Sun Pharmaceutical Industries

Senior Associate, Compliance

Sun Pharmaceutical Industries • $95K — $115K *
Billerica, MA 01821In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BS in chemistry or related scientific field
  • 6-8 years of experience in pharmaceutical manufacturing
  • Expertise in cGMPs and GLPs
  • Proficient in using TrackWise for eQMS data management
  • Strong background in analytical and microbiology testing
  • Experience with radiopharmaceuticals is preferred

Responsibilities

  • Support departments in OOS and OOT investigation closures
  • Conduct technical investigations for product quality complaints
  • Provide resolutions to customer inquiries about product quality
  • Participate in quality investigations and risk assessments
  • Plan and coordinate quality-related projects
  • Perform statistical analysis of quality metrics
  • Compile and present Quality metrics monthly

Benefits

  • Opportunity to drive improvements in quality compliance
  • Collaborative work environment with cross-departmental support
  • Engagement in independent project planning
  • Dynamic role in a fast-paced pharmaceutical setting
  • Potential for career advancement in quality assurance
Full Job Description
The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.

Area Of Responsibility
  • Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
  • Work directly on technical investigations relating to Product Quality Complaints
  • Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries
  • Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
  • Plan and coordinate routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques
  • Perform statistical analysis of critical attributes and trending of QMS events for each commercial product and provide a scientific rationale for the outcome of the conclusion presented in the APQR.
  • Prepare Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline.
  • Compile and report on Quality metrics at monthly Quality meetings, creating presentation materials to identify trends, quality and compliance risks, and make recommendations for changes to processes, procedures, and training, as applicable
  • Manage electronic Quality Management System (TrackWise)
  • Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
  • Develop presentation monthly for QRB meeting based on eQMS, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
  • Follow up with stake holders for timely closures of all open QMS documents and update TW accordingly. Finally, present the status/findings to QRB meetings.
  • Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs
  • Author/revise standard operating procedures (SOPs) and test methods, as required
  • Other duties as assigned

Work Conditions:
  • Office


Physical Requirements:
  • Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb or balance
  • Talk or hear
  • Close vision
  • Computer/office machines
  • Lift up to 10 lbs.

Some travel outside of company facility required

Travel Estimate
  • Up to 5%

Education and Job Qualification
  • BS in chemistry or related scientific field
  • Superior internal and external customer service/people skills
  • Ability to manage multiple responsibilities and projects in a fast paced environment, while performing in an efficient manner


Experience
  • Minimum 6-8 years related experience in a pharmaceutical manufacturing environment
  • Working knowledge of cGMPs, GLPs
  • Strong knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data
  • Strong knowledge of instrumental and wet analytical chemistry
  • Strong knowledge of microbiology testing
  • Strong working knowledge of MS Office software
  • Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc...
  • Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
  • Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture

About Sun Pharmaceutical Industries

Sun Pharmaceutical Industries Limited is an Indian multinational pharmaceutical company that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States. The company offers formulations in various therapeutic areas, such as cardiology, psychiatry, neurology, gastroenterology, diabetology, and respiratory. It also provides APIs such as warfarin, carbamazepine, etodolac, and clorazepate, as well as anti-cancers, steroids, peptides, sex hormones, and controlled substances. Sun Pharmaceutical Industries was founded in 1983 and is headquartered in Mumbai, India.
Learn more about Sun Pharmaceutical Industries
Size
32,300 employees
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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