Job Overview
The successful candidate will have responsibility and oversight for the development and maintenance of quality systems, ensuring compliance with regulatory requirements and industry standards. This includes but is not limited to, Documentation Management, Change Control, Deviation/CAPA processes, oversight of applicable QMS systems supporting and the overall Quality Management Review process.
Responsibilities include providing quality direction and input at Change Control and Deviation Review Boards, assuming oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
Additional responsibilities include overseeing and implementing Quality Agreements relating to area of responsibility, keeping abreast of regulatory initiatives and new guidance/requirements and communicating revised guidelines associated with quality systems.
The role also involves sustained compliance initiatives, including execution of gap assessments in support of revised operating Standards and/or Corporate policies & procedures.
Requirements
Key requirements include a University degree, preferably in an Engineering or Science related discipline. Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Excellent written and verbal communication skills, experience working with dynamic cross-functional teams and proven abilities in decision making, strong organisational skills, including ability to follow assignments through to completion.
Demonstrated ability in problem solving and experience in managing Root Cause Analysis/ Deviation investigations. Detailed Knowledge of applicable Regulatory requirements and experience with Regulatory inspections.
Preferred Experience:
* Working in aseptic operations
* Protein formulation
* Vial and syringe filling
Work Environment
This is a fully onsite contract role, with hours from 08:00 to 17:00. On-Call: You'll be on rotation every 8 weeks. If a bioburner sample pops up, you'll need to step in and handle the testing. OT/DT Eligibility: Yes. Shift Rate: 35%