Assistant Manager, Quality Assurance - Burnaby, Canada - New Beta innovation canada Ltd.

New Beta innovation canada Ltd.

Verified Company

Burnaby, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

ABOUT THE COMPANY
New Beta Innovation Canada Limited (NBI-CA) is a biopharmaceutical manufacturer of hemoglobin-based therapeutics. In Burnaby, BC, we have a state-of-the-art Good Manufacturing Practice (GMP) compliant facility, with custom-designed equipment for commercial-scale production. Our production processes are undergoing validation for rigorous GMP requirements.

Our operations include a full in-house analytical laboratory, a water purification plant, a skilled engineering team, and experts in compliance and regulatory affairs.

These teams work collaboratively to ensure the safety and quality of both our processes and product. With headquarters in Hong Kong, NBI has a global presence in Canada and New Zealand.

We are a committed and innovative team who are passionate about doing great work to make a positive impact on animal health.

We are always on the look-out for creative and passionate people who are eager to contribute to a bigger purpose.

POSITION OVERVIEW

Reporting to the Senior Manager, Quality Assurance & Validation, the incumbent will be responsible for managing QMS activities including change control, CAPA, deviation, quality risk management, supplier qualification, document control and management, data integrity, and internal and external audits.

Pre-employment medical and medical re-examination may be required annually to fulfil regulatory requirements.

1. Key Responsibilities

Act as SME for QMS activities, i.e. change control, CAPA, deviation, quality risk management, supplier qualification, document control and management, data integrity internal and external audits and responsible for making quality decision related to these topics
Lead the regulatory inspection preparation and see through the inspections from QMS perspective
Develop and implement QMS SOPs/policies including but not limited to quality policies, quality manual, change control, CAPA, deviation, quality risk management, supplier qualification, document control and management, data integrity internal and external audits
Review and approve all GMP documentations including but not limited to SOPs, change control, CAPA, deviation, risk assessment, supplier qualification, internal and external audits, batch records, validation/ qualification documents, sample/ test records
Collaborate and work closely with all departments to improve quality culture
Lead vendor qualification program and ensure compliance with regulatory requirements
Review and approve material assessments, material qualification documentation and specifications of production raw material, excipient and disposables
Develop and coordinate internal and external audits plans when necessary, and contribute to drafting the audit plan and report
Support implementation of the process module of the Master Control project from the end user's perspective, ensuring successful project deliverables meet the project schedule
Support in equipment, facility, utility qualification, process, cleaning, analytical and microbial method validation activities
Lead, coach and develop QA team members
Perform other duties as required

2. Knowledge, Skill and Experience

Bachelor's Degree in Life Sciences or relevant field
Minimum 6 years of experience in pharmaceutical or biopharmaceutical industry with minimum 1 year supervisory experience
Strong quality mindset and quality decision making ability with holistic approach
In depth knowledge of quality systems/quality assurance principles
Knowledge and experience with aseptic processing is an advantage
Excellent interpersonal skills and solid leadership skills
Strong Knowledge of cGMP, US and EU regulatory requirements
Indepth understanding of bulk manufacturing, aseptic filling process and biologic product characteristics
Familiarity with inprocesscontrol strategy and final product testing methods
Experience working with inspectors and auditors from various regulatory bodies
High proficiency in MS Word/Excel and has good writing skills
Attention to detail

WHY JOIN NBI?
The best reason is because of our wonderful people and great work environment. If you are looking for a career with meaning and purpose, it's hard to beat working in life sciences.

We provide an attractive compensation and benefits package which recognizes people for their contributions, and comprehensive training and career development opportunities which support our employees' growth with the company.

If you are interested in joining our team, we encourage you to APPLY today