We are hiring for pharmaceutical professionals who are expertise in Managing External Quality Manufacturing (Canada & US Market) for our leading pharmaceutical Clients.

Designation : Coordinator- EQM ( External Quality Manufacturing)

Education : Any Sciences Graduation

Experience : 9 to 13 Years

Roles & Responsibilities :

- Responsible for managing the Quality Product Compliance files for Canada and the U.S. Additionally, acts as the primary Quality contact for products which acts as a contract manufacturer.

- Acts as liaison between manufacturing sites and customer affiliates.

Job Responsibilities :

1. Maintain Quality Product Compliance files for all 3rd party contract manufactured product in which is the Marketing Authorization holder or acts as a distributor for the Canadian market; this includes formally requesting annually with our vendors their current approved master documentation, stability summary reports. Follows up with vendors to ensure all documents are received.

2. Develops and maintains Quality Product Compliance files for the US market place based on current GMP Regulations.

3. Reviews stability program from one year to the next to ensure all product lot stability summaries are provided.

4. Acts as the liaison between external customers and our internal functional groups in order to provide customer quality requests in a timely manner.

5. Interacts with internal functional groups including stability, quality assurance, quality control, regulatory affairs and quality compliance for obtaining the necessary documentation and handling customer requests.

6. Tracks open requests from customers to ensure timely responses. Escalate to senior management any significant delays.

7. Assist External Manufacturing Quality with follow up for new product launch, change control or deviations.

8. Works as a member of a team to achieve all outcomes.

9. Ensure that documents are in full compliance with GMP, and regulatory standards.

10. Performs all work in accordance with all established regulatory and compliance and safety requirements.

11. Performs all work in support of Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of values.

12. Other duties as assigned.

Keyskills : Third Party Manufacturing -Quality External quality Manufacturing TGA Market Canada Market Us Market Quality Compliance External Manufacturing Quality

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