The candidate will be responsible for:
- Writing and managing the change control of technical documents that directly support manufacturing and special projects (e.g. manufacturing work instructions, SOPs, materials specification, inspection procedures, and training procedures).
- Working with the project team in identifying specifications and requirements for materials/equipment destined for use in the manufacture of APIs and to ensure documentation is in place for management of receipt, traceability and compliance under cGMP guidelines.
- Consulting and communicating with suppliers and external sales reps concerning the technical details of the scope of service or deliverable and aligning internal documents accordingly through new document creation or change control.
- Preparing validation protocols, associated reports, and other documentation required to support the successful execution of projects. This would include but not be limited to Equipment and Process qualification documents.
- Providing on-the-job and classroom training to manufacturing employees, including conducting orientation for new employees in standard operating procedures and technical process procedures
- Preparing spreadsheets to track critical project data, preparing summary reports, and identifying process improvement opportunities using statistical methods
- Working with the project team in the identification of instruments, equipment and process aids for the maintenance and manufacturing departments for the Facility, and recommending supplier options.
The successful candidate for this position should have:
- Undergraduate degree in technology/science/or related field or 2-5 years of experience working in the pharmaceutical industry. At least 1 year of technical writing experience is considered an asset.
- Familiarity with Q7A “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients” and the ability to apply the Q7A guidance to project requirements is desired.
- Proficiency in use of MS Office Suite. Smart Drawn and Mini Tab proficiency considered and asset.
- Must be flexible, self-motivated and able to work effectively with a team or independently
- Exceptional interpersonal, written and oral communication skills.
BioVectra offers a competitive salary and benefit package. Interested candidates are asked to apply by choosing the “Apply Now” button.
Closing Date: January 17th 2019
We thank all applicants for their interest but wish to advise that only those selected for an interview will be contacted.