QA Compliance Lead - Mississauga, Canada - Bora Pharmaceutical Services

Bora Pharmaceutical Services

Verified Company

Mississauga, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Location:

***- Mississauga, ON
Date Posted:***- 7/24/2023
Job Number:***- JO Why join Bora?

Competitive salary and generous annual bonus
3 weeks vacations + paid personal and sick days
Extended healthcare and benefits from day
RRSPs and pension plans (matched up to 4%)
An onsite cafeteria with dedicated chefs
Onsite gym, basketball, and tennis courts
A modern and beautiful facility with stateoftheart technology
DEPARTMENT: Quality Assurance

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CURRENT GRADE: 7

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POSITION REPORTING TO: Quality Assurance Manager
General Description:
The Quality Compliance Lead supports external customers, manages the site licenses, and acts as the liaison between the site and third-party companies involved in licensable activities conducted at foreign buildings to:

Consult with site Quality teams and provide input on the QMS for activities relevant to the establishment and maintenance of quality requirements of third-party companies involved in licensable activities conducted at foreign buildings.
Act as the key liaison and provide quality oversight to thirdparty companies involved in, API and Product, licensable activities conducted at foreign buildings, and promptly cascade or escalate information related to Quality requirements and issues to site and customer as required.
Ensure robust documented systems are in place to ensure ongoing regulatory compliance, effective oversight and management of activities conducted by the thirdparty companies.
Provide input and support to activities related to ongoing maintenance of the local licenses including Health Canada requirements for foreign buildings, ensuring licensable activities are accurately reflected.
Establish and monitor thirdparty KPIs to proactively identify, assess, and promptly escalate risks relating to the thirdparty, perform impact assessment of proposed mitigation plans, and monitor implementation of agreed action plans.
Manage routine dayto day activities with the third parties to ensure ongoing compliance by providing timely impact assessment and approval of investigations of nonconformances or other Quality related issues, assessing, and endorsing proposed CAPAs, assessing and facilitating changes, supporting recalls and recall simulations, identifying and endorsing quality improvements etc.
Negotiate site requirements for establishment and maintenance of Quality Agreements, ensuring roles and responsibilities of each party are clearly defined and facilitating documentation requirements and transfer of information and data.
Perform risk assessments relating to distribution processes and recommend and facilitate implementation of appropriate controls to safeguard the quality, integrity, and safety of imported API.
Approve other Quality related documents issued by the Bora or the thirdparty company such as SOPs, Specifications, Risk Assessments, etc.
Provide input for execution of external audits of the thirdparty companies and appropriateness of proposed CAPAs related to audit findings.
Ensure close partnership and alignment with other local teams in relation to site objectives to ensure commercial and project deliverables related to managed APIs are met.
Maintain strong, effective partnerships with third party counterparts to ensure ongoing collaboration, support, and mutually beneficial outcomes.
Provide support to various GxP processes and activities, as required, such as customer and regulatory inspections, new API introduction to the site, management reviews, business reviews by customers and of third parties etc.

Qualifications:

Experience and Skills_
Demonstrated ability to make Quality decisions as it applies to deviations and changes.
Good business acumen with demonstrated ability to influence across functions and levels.
Proven Change Management, Risk Management and Project Management skills
Strong interpersonal, negotiation, collaboration, and relationship management skills to yield positive results.
Good understanding of Continuous Improvement and Problemsolving methods.
Demonstrated proactive approach and sense of urgency mindset with ability to make quick, informed riskbased decisions.
Excellent verbal and written communication skills and a proven track record to influence and promote Quality.
Demonstrated ability to effectively work independently and collaborate in crossfunctional teams.
Education_
Bachelor's degree and minimum 5 years of relevant work experience, or College Diploma in a scientific field (or equivalent degree) and minimum 10 years of relevant work experience.

WORKING CONDITIONS: