Product Quality Specialist
Posted on May 25, 2021 by Elevate Direct
Product Quality Specialist
The Product Quality Specialist will be responsible for ensuring that licensed pharmaceutical products are manufactured and tested in compliance with cGMPs specific to United States FDA and other country health authority regulations (where applicable). The post holder will support and monitor multiple global pharmaceutical suppliers and maintain oversight of all product quality issues. The PQS will function as a core member of the Quality department for McKesson Private Label and ensure product quality issues are resolved and escalated to NorthStar management when required.
Provide Northstar quality oversight for solid dose finished product (OTC drugs), Medical Devices, Combination Drug Products, Dietary Supplements, Cosmetics and Consumer products batches marketed under the Sunmark/Health Mart private labels.
Assume the role of primary quality contact for market complaints for the Sunmark/Health Mart product portfolio. Ensure market complaints are processed, investigated, and evaluated fully as required by NH internal systems and compliance requirements as appropriate to the product under evaluation.
Minimise the risk to Sunmark/Health Mart private label by ensuring a high level of compliance is adhered to for all products within the Sunmark/Health Mart portfolio.
Review and assess critical deviations, Laboratory Investigation reports and CAPA's received from Sunmark/Health Mart suppliers and follow up as needed to ensure effective understanding of the quality issue and resolution.
Assist in the development and/or appraisal of systems for tracking product quality data from Sunmark/Health Mart suppliers. Initiate and maintain Sunmark/Health Mart product database to support product technical oversight of the Sunmark/Health Mart product portfolio within the Northstar Product Quality function.
Prepare metrics to monitor and cross-compare the quality performance of Sunmark/Health Mart suppliers.
4+ years pharmaceutical experience. Ideally the post holder will have manufacturing technical or laboratory experience.
Understanding and knowledge of cGMP and regulatory principles in a pharmaceutical manufacturing environment.
Proven analytical skills and ability to transfer findings into report and presentation formats.
Ability to use judgement to solve complex problems.
Ability to work effectively with others to accomplish goals in a challenging environment.
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