Apotex Inc. Supervisor, QA In Process Manufacturing in Toronto, Ontario

Supervisor, QA In Process Manufacturing

Please note this position is a weekend shift

Job Summary:

Responsible for ensuring that quality product is manufactured 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 QA In Process Department and supervision of staff.

Job Responsibilities:

  1. Oversees daily operations of the QAIP Department which support the business and compliance needs of manufacturing:
  • Assigns work and staff schedule (where applicable) for QAIP Technicians (QS5 and QS6)

  • Troubleshoots manufacturing in-process problems and makes recommendations for solutions in consultation with the department Manager (if required).

  • Identifies non-conformances to the manufacturing management and acts as resource providing support and guidance to AQRS Lead Investigators.

  • Release proposed investigational plan and action tasks in AQRS ensuring completeness and conciseness.

  • Evaluates physical manufacturing defects or variations and determine the impact on the final product and make recommendations for product disposition.

  • Notifies all critical or major non-conformance situations to the Manager immediately.

  • Reviews and approves OOS investigations with QAIP Technicians to determine the cause of the OOS test results and corrective actions needed.

  • Responsible for the issuance and control of all Logbooks used by QAIP personnel at 150 Signet.

  • Ensures adequate department coverage - generate monthly and weekend overtime (OT) schedule.

  1. Ensures that the department operates in full compliance with GMP, GLP, SOP, and established safety standards:
  • Assists in the development and approval of SOPs, work instructions and testing bulletins.

  • Supports initiation of Change Control Records (CCRs) to revise or create testing bulletins, SOPs and WIs.

  • Ensures that the department is properly equipped and the equipment is in good working condition.

  • Ensures new and existing employees are properly trained on SOPs and GMP and that training records are maintained and completed properly.

  • Coordinates projects/activities and generates reports in conjunction with QAIP Technicians as requested by the Manager.

  • Receives and distributes SOP training copies to Department for completion and co-ordinate their return to Training Coordinator by due date.

  1. Recruit, train, develop and manage effectively the ongoing performance of their direct reports, which includes, but is not limited to:
  • Ensuring their Job Descriptions are reviewed, signed and sent to Employee Services, annually.

  • Reviewing and updating employee development plans, ensuring that all employees are properly trained and qualified to execute their duties.

  • Providing coaching, feedback and recognition.

  • Maintains, approves and schedules attendance and vacations of staff.

  • Reviews and approves all staff time sheets/overtime on a weekly basis.

  • Performs Annual Performance Reviews and conducts Interim Performance Reviews/Discussions with all staff.

  • Schedules and organizes departmental meetings and departmental training.

  • Reviews and optimizes processes and SOPs on periodic basis to maximize efficiency.

  • 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.

  1. Responsible to ensure compliance of team members (direct reports) with Safety and Employment policies (e.g., Respect in the Workplace – Prevention of Violence and/or Harassment).

  2. General Responsibilities:

  • Works as a member of a team to achieve all outcomes.

  • Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.

  • Performs all work in accordance with all established regulatory and compliance and safety requirements.

  • All other duties as assigned.

Job Requirements:

  • 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 GMPs and SOPs

  • 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.

System ID: 2016-4868

Job Type: Full Time

Job Industry (Choose up to 3 industries): Pharmaceutical

Career Level: Experienced