Description

Quality Assurance Associate I, PHL

Main Duties and Responsibilities
1. Implement, communicate and maintain company’s quality systems at the facility, in
compliance with Marken’s Global Quality Management System (QMS) requirements.
2. Interact with clients on Quality Assurance (QA)/ GxP related matters under management
supervision.
3. Effectively interact with Marken Departments and stakeholders to maintain that all QA
tasks are appropriately supported by QA.
4. Support on internal audits including report preparation and assessment and tracking of
associated corrective and preventive actions (CAPA).
5. 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, including report preparation.
6. Support client audits and regulatory inspections, including the preparation of appropriate
materials required within those audits when applicable.
7. 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.
8. Identify relevant GxP/ Quality related training needs and deliver or make they are deliver
where required.
9. Ensuring that the Marken Quality System and GxP Program are implemented and
maintained.
10. Assisting in the evaluation of Marken-designated vendors and/or out-sourced activities. 11. Ensuring the accuracy and quality of records and documents.
12. Participate actively in all the internal Quality and/ or designated meetings.
13. Perform QA visual/ physical inspection of pharmaceutical products in accordance with
internal procedure and client specific requirements.
14. Perform a review and release of incoming material receipts in accordance with relevant
SOPs.
15. Perform verification and approval of label printing process and additional labelling/
repackaging activities.
16. Perform the QA activities required Solo (warehouse movement, inventory status control)
for the facility.

Requirements:

Related knowledge of Good Manufacturing Practice, Good Storage Practice and Good Distribution Practice guidelines.
Detailed oriented
Oral and written communication skills
Good interpersonal skills, understanding of GDP and ISO Compliance
Previous experience in Quality Management Systems.
Organized, methodical and efficient approach to work.
Proficient use of Microsoft office
Fluent in English
Minimum of 1 year of experience working in a Quality Assurance role within a GSP/GMP/GDP regulated position.
Minimum High/ Secondary School diploma/ or equivalent with experience in relevant job related skills.