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Senior QA Associate


Nashville, TN 37209
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Job Details

The essential responsibilities of the Snr QA Associate are, at a minimum:

Responsible for expedient and timely management of all regulatory stream activities.

Lead local functions with the requirements for regulatory stream activities.

Identify and escalate as appropriate quality impacting / business critical activities.

Assure Company practices meet TGA, FDA, MHRA, EMA, Health Canada, cGMP and other regulations.

Adhere to compliance plans aligned with company objectives both local and global and support local functions in achieving requirements.

Engage in continuous improvement culture and activities.

The Snr QA Associate role can include, but is not limited to, the following:

+ Administrate the activities for Annual Product Quality Review (report writing, compilation, and tracking).

+ Administrate and coordinate the activities for regulatory inspections including management of the regulatory responses

+ Administrate the activities for regulatory communication management (NtM, FARs, SQRTs, A-QRTs).

+ Administrate the activities for the Vendor Assurance Program (tracking and contract renewal).

+ Administrate the activities for complaints processing (assessment, investigation, tracking, review, approval, escalation, trending).

+ Administrate and coordinate the activities for high risk/market impact incidences

+ Administrate the activities for the Inspection/Audit Program (preparation, administration, management, governance).

+ Administrate the activities for market remediation (product recall)

+ Serve as subject matter experts on aforementioned activities providing technical guidance to team/local functions.

+ Prepare/review and present technical reports on aforementioned functions.

+ Ensure aforementioned functions are conducted in accordance to GMP guidelines and site/corporate procedures.

+ Ensure aforementioned activities meet business needs and agreed targets.

+ Serve as point of contact for site department queries on aforementioned functions.

+ Prepare/review and present regular reports on department performance and quality metrics.

A minimum Bachelor's Degree in an Engineering, Scientific or related discipline is required for this role.

Years of Experience: 5 years, 3 of 5 years in a Quality function.

The Snr QA Associate must also at minimum demonstrate the following knowledge/skills:

+ Knowledge of cGMP and Regulatory requirements for Australia, EMEA and USA.

+ Work prioritization skills

+ Ability to keep comprehensive and accurate records in a multi-faceted environment

+ Well-developed written and verbal communication skills

+ Well-developed consultation and negotiation skills

+ Proficient computer literacy

Able to organize and collate requirements expediently and accurately for presentation to senior / above-site management and regulatory agencies.

Able to identify and escalate as appropriate quality impacting activities.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Apply on the Company Site
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