Senior Associate, Quality Compliance
Company: Sun Pharmaceutical Industries, Inc.
Location: Princeton
Posted on: September 30, 2024
Job Description:
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 EstimateUp 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.
Keywords: Sun Pharmaceutical Industries, Inc., Trenton , Senior Associate, Quality Compliance, Other , Princeton, New Jersey
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