Senior Associate, Quality Compliance

2 months ago

Princeton NJ United States Sun Pharmaceutical Industries, Inc. Full time

Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive maintenance/ calibration/ qualification/ validation as per good manufacturing practices/ good documentation requirements and ALCOA++ principles). Provides supporting role during regulatory, corporate and internal audits.

 

Area Of Responsibility

 

  • Supports Batch certification activities related to USA commercial distribution.
  • Conducts Investigation reviews of Site Deviations (planned, unplanned deviations, OOS/OOT investigations). Ensures conclusions, Corrective and Preventive actions are adequate.
  • Reviews Cleaning Validation related documents (plans, protocols, reports, projects).
  • Supports Quality Risk Analysis related to manufacturing processes and equipment cleaning (e.g. FMEA).
  • Review periodic reports related to cleaning lifecycle (Continued Process Verification (CPV) / Annual Cleaning Review).
  • Ensure compliance to regulatory requirements on product, process, equipment and release procedures.
  • Assists in ensuring FDA Readiness Plan for the facility. Provides support for all regulatory audits, internal/external inspections, and other audits. Responsible for follow ups on all related Operational findings from FDA, other regulatory bodies, internal audits, etc.
  • Participates and conducts mock inspections to prepare the facility for audits and assesses gaps in the system; review documents for compliance to current regulations and cGMPs.
  • Identifies compliance issues and supports the implementation changes for constant improvements. 
  • Supports adherence to SOPs and policies and assists in ensuring that procedures reflect current practice.
  • Performs additional assignments as needed.

 

 

Physical Requirements:

 

  • Must be capable of bending and lifting, moving and/or carrying up to approximately 10 pounds.
  • Ability to navigate office, lab and/or plant floor working environments, stands, ambulates, and reaches.
  • Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Work Conditions:

  • Corporate Office Environment
  • Manufacturing / Production Environment
  • Laboratories
  • Warehouse Environment
  • Field Familiarity Environment

 

Travel Estimate

Up to  10  %

 

 

Education and Job Qualification

  • Minimum of Bachelor’s degree
  • Role supporting seminars and courses are an asset.
  • Thorough understanding of GMPs, specifically those relating to good documentation practices
  • Ability to work effectively in an international multicultural matrix organization
  • Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise, LMS (Learning Management System) etc.
  • Knowledge of project management principles, practices, techniques and tools
  • Strong communication, interpersonal and organizational 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).

 

Experience

  • Minimum of seven (7) years of experience within the pharmaceutical industry
  • Experience working in an international multicultural matrix organization.

 

 

 

 

 

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, and may be eligible for the 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 Taro employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

  • Senior Associate, Quality Compliance Specialist

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries Full time

    Job Summary:As a Senior Associate, Quality Compliance, you will play a key role in ensuring the quality and compliance of our products. You will be responsible for reviewing and certifying batch records, packaging records, and QC lab records to ensure they meet regulatory requirements.Responsibilities:Review and certify batch records, packaging records, and...

  • Senior Associate, Quality Compliance

    1 month ago

    Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive maintenance/...

  • Senior Associate, Quality Compliance

    4 weeks ago

    Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive maintenance/...

  • Senior Associate, Quality Compliance

    4 weeks ago

    Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive maintenance/...

  • Senior Associate, Quality Compliance

    2 weeks ago

    Princeton, NJ, United States SUN PHARMA Full time

    Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive maintenance/...

  • Senior Associate, Quality Compliance

    2 months ago

    Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

    Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive maintenance/...

  • Senior Associate, Quality Compliance

    2 months ago

    Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

    Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive maintenance/...

  • Senior Associate, Quality Compliance

    1 month ago

    Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

    Job DescriptionResponsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive...

  • Senior Associate, Quality Compliance

    1 month ago

    PRINCETON, United States Sun Pharmaceutical Industries, Inc. Full time

    Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive maintenance/...

  • Senior Associate, Quality Compliance

    2 months ago

    Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

    Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive maintenance/...

  • Senior Associate, Quality Compliance

    2 months ago

    PRINCETON, United States Sun Pharmaceutical Industries, Inc. Full time

    Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive maintenance/...

  • Senior Associate, Quality Compliance

    2 months ago

    Princeton, United States SUN PHARMA Full time

    Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive maintenance/...

  • Senior Quality Executive for R&D

    4 weeks ago

    Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    About the RoleThis is a senior leadership position responsible for overseeing the quality and compliance of R&D activities across the organization. The successful candidate will have a strong background in quality assurance and regulatory affairs, with experience in managing cross-functional teams and developing strategies to ensure compliance with relevant...

  • Senior Manager, Compliance and Training

    7 days ago

    Raritan, NJ, United States Joulé Full time

    Title: Senior Manager, Compliance and Training Check out the role overview below If you are confident you have got the right skills and experience, apply today. Location: Remote but local to NJ, NY, PA or CT Type: Embedded Salary: 130-140K Start Date: ASAP Leading Pharmaceutical Company located in NJ is hiring a Senior Manager, Compliance w/ 3+ years...

  • R&D Quality Assurance Senior Associate II

    3 days ago

    Princeton, United States Eastridge Workforce Solutions Full time

    Eastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities. Eastridge is seeking an R&D Quality Assurance Senior Associate II for a company that constantly faces challenges in neuroscience to deliver innovative and vital solutions. Responsibilities:...

  • AML Compliance Senior Associate

    2 weeks ago

    Houston, TX, United States BBVA Full time

    General Summary:The BSA Compliance Associate will be responsible for supporting the bank’s BSA / AML Program. They will assist in performing day-to-day functional tasks related to ensuring Compliance with all applicable BSA/AML and OFAC rules and regulations in each business area; follow all procedures that will ensure the firm’s compliance with the...

  • R&D Quality Assurance Senior Associate II

    3 days ago

    Princeton, United States Aequor Technologies Full time

    Title: Sr. Quality Risk & Compliance Associate Location: Princeton, NJ Duration: 12 MonthsJob Description: This role will work closely with the other team members in Quality Risk & Compliance (QRC) to assist in assessment, reporting on compliance and improvement of processes, tools and systems for clinical trials' execution in a Good Clinical Practices...

  • Senior Support Associate

    4 weeks ago

    Princeton, New Jersey, United States Always Best Care Senior Service Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Senior Support Associate to join our team at Always Best Care Senior Service. The ideal candidate will provide exceptional support to our caregivers and clients, ensuring seamless communication and efficient operations.Key ResponsibilitiesForward all AI receptionist communication to the right...

  • Senior Associate, SOX Control

    4 weeks ago

    UNITED STATES, PA, PITTSBURGH BNY Full time

    Senior Associate, SOX Control & Compliance  At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table...

  • Senior Associate, SOX Control

    4 weeks ago

    Pittsburgh, PA, United States BNY Full time

    Senior Associate, SOX Control & Compliance At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world's financial system we touch nearly 20% of the world's investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create...