Job Summary:
As a Quality Assurance Specialist, you will be responsible for ensuring that our site's quality systems are in place and functioning effectively. This includes providing leadership on validation standards, participating in process validation committees, and reviewing and approving validation documentation.
You will also be responsible for managing the site's inventory of quality agreements, interacting with stakeholders to ensure that quality agreements are current and approved, and completing annual reviews for products and systems.
Furthermore, you will oversee the creation, review, and approval of site quality documentation, including the site master file, validation master plan, policies, and procedures.
Additionally, you will manage the monthly quality council agenda, minutes, and action follow-up, participate in supplier change evaluations, and investigate and review customer complaints.
The ideal candidate will have a minimum of a degree or postgraduate qualification in science, pharmacy, or engineering, as well as strong communication and analytical skills.
Skills Technical: MMD and site quality policies, procedures, and guidelines which relate to the Quality Assurance function and plant quality GMP standards.
Global Engineering Standards Plant procedures and policies Plant equipment and Unit Operations Plant layout Plant documentation Laboratory testing and documentation Validation principles and guidelines Understands key business drivers and uses this knowledge to make decisions and prioritize System Development Life Cycle Business The Specialist must demonstrate the MMD core values and behaviours.
Responsibilities:
* Manage site inventory of quality agreements
* Interact with stakeholders to ensure quality agreements are current and approved
* Complete annual reviews for products and systems
* Oversight of creation, review, and approval of site quality documentation
* Manage monthly quality council agenda, minutes, and action follow-up
* Participate in supplier change evaluations
* Investigate and review customer complaints
Requirements:
* Minimum of degree or postgraduate qualification in science, pharmacy, or engineering
* Strong communication and analytical skills