Associate, QA Validation Ii - Brantford, Canada - Apotex Pharmachem

Apotex Pharmachem

Verified Company

Brantford, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

About Apotex Inc.

Job Summary

The Associate, QA Validation II Co-ordinates the process, cleaning and computer system validation program through the execution of the Master Validation Plan and monitoring progress of activities.

Job Responsibilities
Co-ordinates the process, cleaning and computer system validation programs, which includes

Execution of the Master Validation Plan by scheduling and coordinating the preparation and execution of the protocols, based on current production schedules.

Depending on company needs, more focus may be applied to one or more projects at time.

Monitoring the progress of activities supporting the validation studies, compiling and preparing reports and maintaining summaries and indexes as required.

Provides guidance on validation relate matters and acts as a validation representative on interdepartmental teams as assigned and may also take on the role of project leader, where applicable.

Reviews and approves protocols and reports relating to the qualification of equipment, systems (such as utilities/computer) & facilities (DQ, IQ, OQ, PQ) and acts as a team member to provide regulatory guidance on ongoing projects, where applicable.

Assesses and approves devitaions/non conformances, trend data and proposed changes to processes (i.e., MBR changes), systems, equipment and facilities for impact on the validated status and provides recommendations for revalidation where necessary.

Prepares validation data summaries for Annual Product Reviews as well as other reports etc.
Reviews and approves documents, procedures, reports, certificates, etc., in accordance with SOPs and GMP standards for active pharmaceutical ingredients.

Contributes to the development of effective projects by assessing priorities, evaluating the various typs of documents required and ensuring appropriate training is provided and acts as project leader as assigned by management.

Reviews current and proposed regulatory guidelines and regulations and prepares summary and impact analysis reports for management review. As necessary, develops and acts implementation plans.
Works in a safe manner collaborating as a team member to achieve all outcomes.

Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.

Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.

All other relevant duties as assigned.

Job Requirements
Education
Education at University, or equivalent, level in a related scientific discipline.
Knowledge, Skills and Abilities
Practical validation experience and understanding of GMP regulations related to manufacturing equipment qualification and validation (process, cleaning and computer system) requirements in Canada, USA and International (ICH)
Effective and skilled communication (verbal and written) including good report writing, organizational and project management sklls.
Experience
Minimum 5 years related experience in the Pharamceutical Industry

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.