Manage the cGMP compliance at site focusing on Quality Systems, processes, procedures and controls ensuring that the cGMP documentation and records conforms to established standards and in compliance to regulatory requirements.
Area Of Responsibility
Implement and manage the records in electronic Quality Systems, such as QMS, EDMS, and LMS, etc. providing procedures and training for employees to effectively use the electronic Quality Systems
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
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 and vendor audits.
Facilitate and follow up with stakeholders with regard to responses to audit observations
Prepare annual internal audit schedule and perform execution of the 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 point of contact with corporate activities and projects.
Issuance of Quality Alerts, coordinate with Corporate Quality team for FAR/Recall as per procedures
Other duties as assigned
Work Conditions:
Office Environment
Manufacturing / Production Environment
Warehouse Environment
Field Familiarity 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
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