Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the Country. We have an incredible team of bright, passionate, and committed individuals, who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to the healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our growing team.
Responsible for ensuring that quality product is manufactured/packaged according to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and established Standard Operating Procedures (SOP). This includes responsibility for the daily operation of the In Process Laboratory and supervision of staff.
* Oversees the daily operations of the QAIP Department including the assignment of work (where applicable) to Technicians, Document Reviewers, and Coordinators.
* Troubleshoots manufacturing/packaging in-process problems and makes recommendations for solutions in consultation with the department Manager (if required).
* Identifies non-conformances to the manufacturing/packaging management and acts as resource providing support & guidance to AQRS Lead Investigators.
* Release proposed investigational plan and action tasks in AQRS ensuring completeness and conciseness.
* Evaluates physical manufacturing/ packaging defects or variations and determine the impact on the final product and make recommendations for product disposition.
* Ensures new and existing employees are properly trained on SOPs and GMP and that training records are maintained and completed properly.
* Assists in the development and approval of SOPs, work instructions and testing bulletins.
* Notifies all critical or major non-conformance situations to the Manager immediately.
* Reviews and approves OOS investigations with QAIP Technicians and Coordinators to determine the cause of the OOS test results and corrective actions needed.
* Advises DI to initiate Change Control Packages (CCs) to revise or create testing bulletins, SOPs and WIs.
* Coordinates projects/activities and generates reports in conjunction with Technicians, Document Reviewers and Coordinators as requested by the Manager.
* Ensures that the department operates in full compliance with GMP, GLP, SOP, and established safety standards.
* Ensures that the department is properly equipped and the equipment is in good working condition.
* Maintains, approves and schedules attendance and vacations of staff.
* Performs annual Performance Reviewers and conduct Interim Performance Reviews/Discussions with all staff.
* Schedules and organizes departmental meetings and Departmental training.
* Reviews and optimizes processes and SOPs on a periodic basis to maximize efficiency.
* Reviews and approves all staff time sheets/overtime on a weekly basis.
* Responsible as Departmental IS Lead for liaising with the IS Business Unit Lead, completing all required IS paperwork and coordinating new employees IS requirements.
* Monitors group and individual activity via the IP Secure database and addresses as required.
* Conducts departmental communication meetings.
* Responsible for the issuance and control of all Logbooks used by QAIP 150 Signet.
* Ensures adequate department coverage - generate monthly and weekend OT schedule.
* Receives and distributes SOP training copies to Department for completion and co-ordinate their return to HR by due date.
* Covers for the duties of the Manager in their absence.
* Bachelor of Science Degree or equivalent in a related discipline
* 3-5 years supervisory experience in a pharmaceutical environment
* Excellent written and verbal communication skills
* Excellent ability to follow GMP and SOP
* Well-versed in cGMP requirements and has the ability to apply cGMP rules to the work-area
* A logical and detailed oriented personality
* Demonstrated ability to provide direction and supervise others through previous work experience
* Proven analytical and problem-solving skills
* Must be familiar with overall pharmaceutical manufacturing/packaging and quality processes
* Ability to manage multiple priorities in a fast-paced and changing environment
* Ability to supervise others
* Strong organizational, time management and interpersonal skills
* Familiarity with Word, Excel, Access, and Windows is required
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
*This position is located at our Etobicoke site at Steeles and Hwy 27*