About the role:
Reporting to the Plant Manager, the Operations Support Specialist is responsible for working closely with the Production and Maintenance departments, leading CAPA closures and updating SOP’s to ensure compliance with the overall site Quality Management System and cGMP’s.
What you'll do:
- Writing, editing, reviewing, updating the departmental technical documents such as the Standard Operating Procedures (SOP’s), Protocols and summarizing technical information
- Work to close approved CAPA’s through completion of the listed action steps. Will directly implement documents changes and updates. Assists in identifying the mitigations, where applicable, and with the appropriate Corrective and Preventive actions
- Develop written reports using Technical Writing skills including but not limited to investigation plans, investigation results in alignment with Non-conformance and CAPA process requirements
- Delivers all required document updates (SOP, MBR, Deviations, Specifications etc.) as required for the investigation work being conducted and help facilitate training as required
- Communicates and builds relationships with all levels within the company. Presents solutions and solicits feedback from management and stakeholder groups
- Demonstrates a thorough understanding of regulatory guidance requirements. Accurately incorporates regulatory requirements governing proposed changes into written documents.
- Adheres with all compliance programs and company policies and procedures.
- Any other duties as assigned
What you bring to the role:
- Bachelor’s degree specializing in Engineering or Science in related discipline
- Advanced knowledge of the operational principles of pharmaceutical manufacturing equipment and processes as they pertain to liquid filling
- Excellent document and report writing using scientific language
- Excellent at reviewing documentation written by other writers to ensure clarity, completeness, accuracy, and overall quality standards
- Expert skills in Microsoft Suite.
What we offer:
- Competitive Salary
- Paid Holidays
- Competitive Vacation Policy
- Paid Sick Days
- Competitive Benefits plan
- Employee Assistance Program
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager.