QA Compliance Specialist - 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:***- 8/23/2023
Job Number:***- JO
Why join Bora?

Competitive salary
A modern and stateoftheart facility
An onsite cafeteria with dedicated chefs
Onsite gym, basketball, and tennis courts

Click here for a video tour of our Mississauga facility:

TITLE:
QA Compliance Specialist

-
DEPARTMENT:Quality Assurance

-
POSITION REPORTING TO: QA Manager-Projects
THIS IS A FULL TIME CONTRACT POSITION

General Description:

QA Compliance Specialist to act as the QA support for new project transfers into Bora.

Provide quality support for areas, such as Analytical, Engineering, Process Leads and Production to ensuring GMP compliance and client regulatory requirements are maintained.

Their key responsibilities are listed but not limited to the following.

Responsibilities:

Plan and proactively manage compliance requirements for a complex mix of products for global markets.
Provide GMP compliance support for various projects and initiatives including product transfers.
May be required to issue or approve Master Data, Standard Operating procedures, Master forms, Technical Reports, Risk Assessments, Raw Material and Product Specifications, Analytical Test Methods, Supplier or Customer Quality Agreements and other Quality related documents.
May be required to manage various aspects of the supplier management program including the assessment of supplier compliance documentation to ensure regulatory compliance, supplier change and nonconformance notifications and regulatory quality alerts to ensure ongoing site compliance.
Review site master data and other internal information to ensure ongoing compliance through the interpretation of customer/supplier requirements, regulations, and data.
May be required to lead or support internal audits and actively participate in regulatory and customer inspections.
Analyze processes and systems, identify vulnerabilities/gaps, establish remediation plan and lead implementation activities.
Lead or support investigations using root cause analysis tools with multifunctional groups and develop CAPA plans or confirm effectiveness of CAPA plans.
Lead or contribute to CGMP training of staff.
Support other team activities including but not limited to entering data in various electronic systems, generating monthly quality metrics, issuing declaration statements etc.

Qualifications:

Experience and Skills_
3 5 years of experience in a similar role in the pharmaceutical or related industry
Education_

Required:

College Diploma in Science, Engineering, or a related field or equivalent on the job experience through years of service in the Pharma or related industry

Preferred:

Bachelor's Degree
Strong knowledge of regulatory framework and demonstrated ability to interpret regulations and make informed decisions.
Support projects or change initiatives and provide advice on compliance requirements.
Ability to effectively communicate cGMP requirements to individuals.
Excellent interpersonal and communication skills.
Good technical writing skills. Thorough attention to detail is key for this role.
Good computer skills and data management skills