Qa Product Manager

Position: QA PRODUCT MANAGER
PRIMARY

PURPOSE:

* Provide customer service and serve as primary QA point of contact for customers.

* Review and approve quality documents for customers such as Deviations, Master Batch Records, Change Controls, Validation Protocols and Reports, FG specifications and Test Methods.

* Coordinate required functions across the site and with customers to ensure timely review and approval of deviations, change controls, audits CAPAS, corrections and effectiveness checks.

* Develop Technical Quality Agreements and collaborate with customers to align customer and FS quality systems.

* Develop and nurture customer partnership to ensure alignment and consensus.

* Participate and coordinate meetings with customers as part of QA oversight for customer products.

* Generate quality metrics, trackers, and reports for management and customers to characterize the health of the client relationship and state of quality systems.

* Promote Compliance within the site at all levels and cross functional Teams.

* Participate in the Internal Audit Program by performing site audits as required by QA Management.

* Provide support during customer audits and Health Authorities inspections.

* Support EHS audits (regulatory and customers) to scribe- file documents as required.

* Conduct Investigations/CAPAs for quality events, ISO event, calibration events and safety quality related events as required by management.

* Promote GMP and safety throughout the facility by training and coaching personnel to quality, regulatory and safety as tasked.

* Accurately reviews and records data.

* Promote continuous improvement and customer satisfaction.

* Participate in other activities as assigned by the Director of QMS.

QUALIFICATIONS:

* Experience working in Quality Assurance, QMS, Validation and Compliance.

* Experience in a regulated industry (e.g., Food and Drug Administration).

* Bachelor's Degree in Science (Chemistry, Microbiology or Biology preferred) required

* A minimum of five to ten years related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries.

CRITICAL

SKILLS AND ABILITIES:

* Working knowledge of FDA regulations for drugs and/or medical devices.

* Skill in written and oral communications and in establishing effective interpersonal relationships.

* Ability to use a personal computer and peripheral equipment to accurately enter and analyze data and produce reports.

* Ability to make quality decisions and act accordingly.

* Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.

* Ability to perform effectively under conditions of fluctuating workload.

* Ability to handle and resolve recurring problems.

* Communicate with others clearly and concisely.

* Ability to work in a fast-paced environment - sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.

* Strong initiative, technical commitment and contribution to company and departmental goals