Bora Pharmaceutical Services
Supervisor QA Compliance
|Hiring Organization||Bora Pharmaceutical Services|
|Post Name||Supervisor QA Compliance|
|Qualification||Bachelor’s Degree or College Diploma in Science, Engineering, or a related field or equivalent|
|Employment Type||Full Time|
|Work Hours||8 Hours|
|Salary||CAD 25 To CAD 30 Per Hour|
|Location||Mississauga, Ontario, Canada L4T 4A1|
QA Compliance Supervisors ensure Bora’s products and processes meet established quality standards. They provide quality oversight and coaching for a myriad of areas including GMP compliance requirements to ensure inspection readiness of the site at all times. Responsibilities are accomplished through the support of a small team of direct reports.
- Plan and proactively manage compliance requirements for a complex mix of products for global markets.
- Lead, or participate in various Quality Systems improvement projects and provide GMP compliance oversight and coaching to individuals, teams, or projects across the site.
- Be responsible for all compliance requirements pertaining to the document management center, including administration, storage, and archiving of documents.
- Ensure the document management system and other relevant systems are operated and maintained in a validated state. Act as system administrator of area electronic systems including access management and reviews.
- Provide coaching to direct reports and individuals/teams site wide on cGMP requirements pertaining to document management. Maintain the site document retention matrix to ensure compliance with regulatory and customer requirements.
- Manage a small team, including team/people development, coaching, work assignment and prioritization, performance management, and KPI maintenance.
- Provide guidance and leadership to the team responsible for authoring SAP Master data, Pharmacopoeia Assessment Reports, Vendor Certification Program Reports, Material and Product Specifications, Analytical Test Methods, Quality Agreements, Technical Reports, and Risk Assessments to support compliance requirements, and other Quality related documents.
- Responsible for Quality approval of documents including but not limited to those authored by direct reports.
- Actively participate in inspections in various roles, including leading the inspection support team.
- Lead investigations using root cause analysis tools with multi-functional groups, analyze processes and systems, identify vulnerabilities/gaps/root cause, establish remediation plan and where applicable, lead implementation activities.
- Develop GMP training material and lead cGMP training of staff.
Experience and Skills:
- Minimum 5 – 10 years experience in a similar role in the pharmaceutical or related industry.
- Bachelor’s Degree or 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.
- Strong knowledge of regulatory framework and demonstrated ability to interpret regulations and make informed decisions.
- Demonstrated ability to participate in projects or change initiatives with the ability to make sound quality decisions.
- Ability to influence and coach individuals on cGMP requirements.
- 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.
To apply for this job please visit hudsonrpo-am.secure.force.com.