- Implement, communicate and maintain company's quality systems at the facility, in compliance with Marken's Global Quality Management System (QMS) requirements.
- Interact with clients on Quality Assurance (QA)/ GxP related matters under management supervision.
- Effectively interact with Marken Departments and stakeholders to maintain that all QA tasks are appropriately supported by QA.
- Support on internal audits including report preparation and assessment and tracking of associated corrective and preventive actions (CAPA).
- Support audits of external service providers as part of the vendor selection process. Follow up and tracking all commitments for actions or changes made by Marken from previous audits.
- Support client audits and regulatory inspections, including the preparation of appropriate materials required within those audits when applicable.
- Collate issues, CAPA, Risk Assessment, Change control and training metrics and identify quality improvement initiatives. Oversee activities that conclude on the appropriate close-out of all CAPA entries.
- Identify relevant GxP/ Quality related training needs and deliver or make they are deliver where required.
- Ensuring that the Marken Quality System and GxP Program are implemented and maintained.
- Assisting in the evaluation of Marken-designated vendors and/or out-sourced activities.
- Ensuring the accuracy and quality of records and documents.
- Participate actively in all the internal Quality and/ or designated meetings.
- Perform QA visual/ physical inspection of pharmaceutical products in accordance with internal procedure and client specific requirements.
- Perform a review and release of incoming material receipts in accordance with relevant SOPs.
- Perform verification and approval of label printing process and additional labelling/ repackaging activities.
- Perform the QA activities required Solo (warehouse movement, inventory status control) for the facility.
- Perform activities assigned by the QA Management.
- Travel as reasonably requested by the Line Manager to the performance of duties.
- Support your line manager, that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
- High/ Secondary School diploma/ or equivalent with experience in relevant job related skills
- 1+ years of experience working in a Quality Assurance role within a GSP/GMP/GDP regulated position
- Related knowledge of Good Manufacturing Practice, Good Storage Practice and Good Distribution Practice guidelines
- Related knowledge of local regulations
- Detailed oriented and organized with a methodical and efficient approach to work
- Good interpersonal skills, oral and written communication skills
- Proficient use of Microsoft office
- Fluent in English
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Quality Assurance Associate - Fairdale, United States - Marken
Description
About Marken
Marken always finds a way to connect patients with new medicines, in all corners of the world. Our global presence provides an opportunity for all employees to collaborate internationally, offering visibility and opportunity to contribute to the company's success.
Main Purpose:
The Quality Assurance Associate I (QAA I) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes, and policies required to manage and control Marken's Storage, Distribution, and Transportation, Kit Production Facility.
The QAA I also need to ensure compliance with applicable regional and local regulations and requirements, and customer requirements as appropriate, but not limited to: current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), ISO 13485 and ISO 9001.
Main Duties and Responsibilities:
Moving Our World Forward by Delivering What Matters.
EEO and Veteran Employer
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