Quality Assurance Manager - Brampton, Ontario Canada - 18740

This closed position was filled. Check out our Jobs Search Page for our current open positions similar to this one.

JOB DESCRIPTION

Job #: 18740
Title: Quality Assurance Manager
Job Location: Brampton, Ontario - Canada
Employment Type:
Salary: contact recruiter for details
Employer Will Recruit From: Regional
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


Our client located in the GTA West is looking for a strong and qualified candidate to fill this 12-month contract position.

 

JOB DESCRIPTION

Responsibilities:

·        Responsible for providing leadership and guidance to the team to establish/straighten performance of the market release team, this should be done through employee development and performance management

·        Accurately and efficiently manage product release into the Canadian Market

·        Properly establish and maintain complaint and QA release systems

·        Accountable for managing the review of batch releases and compliance documents that are required for the release of imported products in the Canadian Market

·        Oversee and manage the 3rd party lab testing for relevant products, efficiently supervise the new contract lab qualifications and method transfer verifications

·        Properly identify and schedule the site priorities pertaining to the collaborative review of incoming product for the release into the Canadian market in support of Supply Chain and Customer Service to fill orders

·        Efficiently and effectively coordinate the warehouse QA activities for incoming inspections and releases created on predetermined priorities

·        Actively work with storage and logistics firms in regards to managing relations, audits, training and communications

·        Effectively communicate and collaborate with Marketing and Product Supply teams to confirm suitable release priorities

·        Responsible for communicating with suppliers for the receipt of release documents and supporting matters

·        Proficiently develop and maintain SOP’s on the process to confirm complaint execution of the releases

·        Responsible for managing annual full batch review program

·        Proficiently develop and implement strong tracking management strategies

·        Efficiently and effectively develop an Annual Full Batch Release Plan and generate monthly forecasts to the sites and vendors

·        Accountable for communicating with company sites and CMOs to ensure full batch record receipts are in accordance with the schedule

·        Proficiently established and develop suitable documentation controls and archiving activities

·        Properly identify risks and collaborate with product manufactures to develop corrective actions

·        Responsible for developing and implementing a Product Master File Management Program

·        Efficiently create and maintain product lists and electronic Master File databases

·        Responsible for accurately developing and maintaining a structured product Master binder and confirm timely updates of their content and ensure security of the information

·        Consistently ensure that there is proper oversight and control of the document absorption processes

·        Accountable for ensuring timely receipt of revised Master Documents and product specifications for the manufacturing sites and vendors

·        Responsible for ensuring the Change Control process is in line with compliance on a consistent basis

·        Responsible for developing and managing the Unique Identifier Program and Program Tracker

·        Effectively and efficiently collaborate with sites and vendors to confirm the unique identification meets Health Canada guidelines

·        Accountable for staying in consistent communication with the manufacturing sites and ensuring the timely update of letters in the Product Master File

·        Proficiently and proactively identify the list of the shipped products and transportation risks

·        Responsible for developing the risk analysis program and trending technics for evaluating temperature excursions incidents in an efficient manner

·        Accountable for developing the template for the Study protocol and managing the execution of the studies in accordance to the plan

·        Accountable and responsible for leading the change control and deviation investigation programs

·        Proactively begin and approve the change control initiation for the supplier in regards to critical and non-critical changes

·        Professionally arrange communications with sites to confirm that Quality Canada will be able to review all relevant Change Control records in the Global QMS Trackwise System before their initiation

·        Consistently review and approve the change control records and review their content, risk-based assessments and all the associated actions

·        Proactively confirm that employees have the correct training and access in the Global QMS Trackwise system

·        Responsible for the Canadian Training program for the parent company

·        Accountable for establishing the implementation of the correct training courses in accordance with the assessment and consistently manage the annual GMP training program

·        Responsible for being a Superuser for the site employees on the Learning Management System (LMS)

·        Efficiently create, maintain and monitor the parent company weekly release metrics

·        Consistently monitor updates in regards to Regulatory Authorities and Industry guideline documents

·        Efficiently and effectively manage and monitor the activities for new product launches

·        Accountable for interacting with internal groups in regards to phase development planning and reviews to confirm the according support for analytical method transfers from the manufacturer to the contract laboratory in regards to new product launches

·        Proactively recognize Global Documents related to the programs and manage the implementation process based on the results of the gap assessment

QUALIFICATIONS

Requirements:

  • Bachelor’s Degree in a Science or Pharmaceutical discipline
  • Minimum 8 years experience in Quality Assurance inline with Health Canada in the pharmaceutical industry
  • Strong experience working directly with Regulatory Authorities
  • Strong experience in Quality Assurance in combination with Validations
  • Excellent understanding of GMP and Regulatory requirements in the pharmaceutical industry
  • Excellent Communication skills, both written and verbal
  • Strong presentation, technical writing, negotiation and organizational skills
  • Ability to manage multiple priorities at once with the ability to meet scheduled deadlines

 

 

***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections

Education:
University - Bachelor's Degree/3-4 Year Degree