Job Summary

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 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 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