Senior Associate, QA Compliance (PQC/ APQR)

Job Summary

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

• B.S. 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

The presently-anticipated base compensation pay range for this position is $98,000 to $119,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.