Quality Assurance Team Leader

3 weeks ago

Brampton, Canada Nova Pack Ltd. Full time

**Do you have experience working in a Quality environment? **Our Quality department is currently looking to add a QA Team Leader at our Brampton location.

This is a great opportunity to take your career to the next level and be part of a team that works very closely with pharmaceutical clients and contributes to the ongoing processes of assurance and enhancement of quality.

**About Nova Pack**:
Nova Pack is a third-party contract packing (co-pack), re-packaging and assembly supplier-partner supporting CPG, Healthcare, OTC, Pharma, Medical Device, HABA / Cosmetic and NHP companies. Nova Pack customers are typically quality conscious, world-leading multi-national organizations in their respective industries and demand only the best when it comes to the handling of their products. Nova Pack has a proud tradition of integrity in dealing with its customers, its employees, and its suppliers.

**About the Role**:
Reporting to the Supervisor of Quality Assurance & Regulatory Affairs, The Team Leader QA provides leadership assistance to the Supervisor QA in coordinating QA activities at the site related to the receipt, co-packing and labeling of Client products at Nova Pack. The Team Leader acts as back-up for the QA Supervisor. The Team Leader QA is also responsible for the execution of QA specific requirements at the branch including performing RPIC/ARPIC functions as required under the Controlled Drugs and Substances Act and related regulations or Canadian QA functions. The Team Leader QA will promote and consistently exemplify the organizations values.

In addition, the Team Leader QA will adhere to and promote all relevant procedures to ensure that facilities maintain a state of GMP compliance at all times. The Team Leader QA is responsible for performing job duties in a safe manner according to Nova Pack’s operational, safety and quality procedures and in compliance with the Ontario Occupational Health & Safety Act.

**Other Responsibilities**:

- Assist in reviewing procedures pertaining to QA processes,
- Ensure SOP & other controlled document training is up-to-date for QA team,
- Escalate regulatory non-conformances to management,
- Assist in conducting annual GMP training of Nova Pack employees,
- Conduct SOPs/GMP issues review sessions with site Production & QA employees,
- Provide training to QA team,
- Participate in internal facility audits ensuring observations are addressed. Ensure QA participation in site QA/Production meetings,
- Participate in external audits including Clients and Regulatory auditors. Participate in addressing audit observations,
- Participate in Client meetings as needed,
- Promotes all Quality systems and GMP requirements at the site,
- Ensure adequate QA staff coverage for all shifts at the site to support on-going activities and ensure compliance to GMP,
- Ensure materials & products are received and shipped following Nova Pack procedures,
- Ensure work order approval and issuance of materials & product to the packaging line following Nova Pack SOP. Ensure all in-process checks and other activities requiring QA oversight are executed during product packaging/labeling,
- Release products for shipment according to Nova Pack SOP,
- Put product on quarantine or hold following Nova Pack SOP,
- Ensure review of weekly temperature graphs and initiate deviations for temperature excursions per Nova Pack SOP. Ensure appropriate steps are taken to protect the product integrity during a temperature excursion. Inform QA Management and the Clients,
- Ensure completion of HVAC preventative maintenance & other equipment calibration and review/approve records. Ensure review of logs by site QA,
- Ensure site sanitation and equipment cleaning is completed following Nova Pack SOP,
- Respond to incidents at the site impacting quality including during off hours. Escalate critical issues to QA & Production management,
- Initiate deviations when applicable and following Nova Pack procedure and participate in investigation. Ensure deviation reports are forwarded to Clients as applicable.
- Participate in Nova Pack self-inspection program,
- Ensure appropriate storage of GMP documents,
- Support Supervisor QA and perform other duties as required.

**RPIC/ARPIC duties**:

- Maintain RPIC/ARPIC designation,
- Ensure security system is armed/disarmed for Precursor areas and address any issues observed during Precursor areas security testing and inspections.
- Ensure destruction procedure for Precursor products is followed by the site.
- Provide support as required in ensuring Precursor product inventory counts are performed according to SOPs and the Controlled Drugs and Substances Act and related regulations.
- Support filing with Health Canada of new Precursor site licenses and renewal of existing licenses including required police checks,
- Support filing with Health Canada Precursor suspicious activity reports.

**Who you are**:

- Bachelor of Science degree from a recognized Canadian university or

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