Quality Assurance Associate
QA / QC, Canada.
The Quality Assurance Associate is responsible for ensuring that Ferring Inc. and its associated fabricators, packagers and testing sites comply with current Good Manufacturing Practices (GMP) Guidelines of the Food and Drug Act and Regulations. The position is also responsible for ensuring that Ferring Inc. complies with global policies and standards as they relate to GXP.
- Responsible for the compilation and review of documentation in support of product releases (COA, COC, Master documents), Includes coordination of testing programs with vendors.
- Initiation of change control, deviations and incidents concerning product quality issues, customer complaints, storage/distribution aspects and oversight of GXP vendors.
- Writing and distribution coordination of GXP SOPS with all internal stakeholders as well as manage the local implementation of Ferring Global SOPs. Assigned Deputy Documentation Responsible Person (Deputy DRP).
- Reviews documentation for compliance in the release of finished product including GMP master and batch records and analytical reports.
- Co-ordinates the analytical evaluation of samples, including re-testing and ordering reference standards as applicable.
- Assists in investigation of product complaints and deviations (Out of Specifications).
- Assists in the investigation of customer complaints.
- Performs routine vendor audits of domestic vendors and ensures vendor management systems are in place.
- Prepares, reviews, and approves documents such as specifications and certificates of analysis.
- Assists in the execution of validation and qualification projects, method and technology transfers.
- Prepares and reviews stability summaries and reports.
- Provides back-up support to the QA Manager as required, as well as back-up support to the Canadian Regulatory department as it pertains to Chemistry, Manufacturing and Control (CMC) updates.
- Bachelor of Science (Life Sciences).
- 2-4 years of quality assurance experience preferably in a pharmaceutical environment.
- Strong computer skills (MS applications).
- Strong analytical, quantitative, organizational and problem solving skills.
- Excellent attention to detail.
- Solid decision making skills with strategic mindset.
- Ability to work well independently as well as in a team environment.
- Self-directed and driven to accomplish goals and meet deadlines.
- Effective time management skills and ability to prioritize workload.
- Excellent written and verbal communication skills, strong presentation skills.
- Comfortable working in a fast-paced environment and handling multiple tasks/priorities.
Qualified candidates may submit their resume with cover letter by email to firstname.lastname@example.org, quoting the position title in the subject line.
We thank all interested applicants, however, only those under consideration will be contacted.All Vacancies