Senior Compliance Manager
Company: SUN PHARMA
Location: Billerica
Posted on: May 15, 2022
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Job Description:
Job description: Job Summary Manage the development,
establishment, and maintenance of Quality Systems, policies,
processes, procedures and controls ensuring that performance and
quality of cGMP documentation and records conforms to established
standards Area Of Responsibility Implement electronic Quality
Systems, such as eQMS, EDMS, and LMS, providing procedures and
training for employees to effectively use the electronic Quality
Systems Design, plan, implement, and manage documentation programs,
policies, and procedures that support company objectives and
regulatory requirements Supervise the QA Documentation department
in the creation, issuance, maintenance, archiving, and storage of
cGMP and cGXP controlled documentation and records. Manage
electronic document processing, retrieval, and distribution systems
(EDMS), electronic learning management system (LMS), electronic
Quality Management System (TrackWise), etc--- Administer document
and system access rights and revision control to ensure security of
system and integrity of master documents Lead Monthly Quality
Review Board (QRB) meetings, Quality Investigation Board (QIB).
Supervise the creation of an annual training calendar and other
training initiatives at the site Provide expertise and input to
other functional areas affecting controlled documents and records
Assist with FDA and other compliance audits including corporate
audits. Facilitate and follow up with stakeholders with regard to
responses to audit observations. Prepare annual internal audit
schedule and perform execution of same. Oversee site vendor
management program including performing annual vendor risk
assessment. Oversee harmonization efforts between corporate and
plant Quality procedures and policies Provide QA review of Annual
Product Reviews (APRs) to identify trends and recommend CAPA as
needed Provide QA review of quality events such as
unplanned/planned deviations and change controls. Participate in
investigation team efforts to determine root cause for critical
quality events and recommend appropriate CAPA Develop presentation
materials for upper management to disseminate on the topics of
quality issues, QMS initiatives, and related projects Participate
in Regional Quality related projects and initiatives, acting as an
ambassador between corporate and plant Issuance of Quality Alerts,
FAR/Recall as per internal procedures. Other duties as assigned
Work Conditions: Office Environment Manufacturing / Production
Environment Physical Requirements: Stand, walk, sit, use hands and
fingers to handle or feel, reach with hands and arms, climb or
balance, stoop, kneel, crouch or crawl, hear or talk, taste or
smell Operate computer/office machines Gowning, safety glasses,
gloves, booties Close, distance, color and peripheral vision; depth
perception, ability to adjust focus Lift up to 10 lbs. Travel
Estimate Up to 10% Education and Job Qualification BS in chemistry
or related scientific field Minimum Ten (10) years of related
experience in pharmaceutical (manufacturing) environment, biotech
industry, Quality Assurance, Quality Control and/or production, or
FDA regulated industry. Experience Strong working knowledge of a
Quality Management System (QMS) and adherence to 21 CFR Parts 210,
211; aseptic drug manufacturing experience a plus Superior internal
and external customer service/people skills Ability to manage
multiple responsibilities and training projects in a fast paced
environment, in an efficient manner Ability to present self in a
professional, credible manner and communicate effectively at all
levels of the organization Ability to prioritize and organize own
work, multi-task, meet deadlines and keep commitments Experience in
developing and managing various types of training initiatives
expected Excellent administrative & organization skills Strong
Presentation and MS Power Point Skills Positive attitude; values
others and works well independently and in a team environment
Excellent verbal, written and interpersonal communication skills
Works under minimal supervision following established procedures
along with own judgment. Expert knowledge of electronically based
Quality Systems Working knowledge of pharmaceutical and medical
device documentation and change controls Experience with continuous
improvement programs and project management skills Working
knowledge of applicable domestic and international standards and
regulations
Keywords: SUN PHARMA, Billerica , Senior Compliance Manager, Executive , Billerica, Massachusetts
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