- Provide training to QA specialists as needed.
- Product Market Release: Lead and train others in market releases of batches of drug, NPN, medical devices and cosmetic products for the Canadian Market.
- Management of GMP compliance issues with manufacturing sites, contract packagers, warehouse and contract laboratories, shipping and storage conditions.
- Lead product returns process, manage review and approval of all returned products.
- Establishment Licenses: Responsible in maintaining various site licenses with regards to DIN, Medical Device and NPN products.
- Review of GMP related documents, such as transportations, Annual Product Quality Review (APQR), Yearly Biologic Product Report (YBPR), on-going stability data, validation documents and master batch records.
- APQR - Write Market APQR and collaborate with Regulatory team in completion of the report.
- Deviations/ CAPA
- Quality Documentation
- Review and approve test reports and out of specifications from contract laboratories.
- Provide guidance to contract laboratory for any out of specification procedure and reports.
- Complaint - Provide guidance complaint investigations, troubleshooting, general issues, and trending to identify areas for improvement and CAPA.
- Manage internal change control process.
- Audit – Encompasses in readiness activities related to internal, regulatory agencies and notified body inspect and conduct periodic Internal audit.
- Assist QA manager to underwrite to KPIs associated with aspects of QMS activities.
- Vendors/ supplier management - Assist QA manager in the identification, approval/ qualification, and ongoing maintenance of vendors or suppliers.
- Bachelor's degree required (Engineering or Sciences).
- 5 to 7 years of related experience in Quality Assurance within a pharmaceutical and Medical Device industries with at least 2 years' experience with emphasis in Importation and Distribution of pharmaceuticals, Medical Device and NHP products.
- Understanding of pharmaceutical manufacturing and laboratory processes.
- In depth knowledge of applicable Health Canada and global pharmaceutical regulations (e.g. ICH)
- Experience auditing preferably with an auditing certification
- Basic MS Office computer and software proficiency
- Experience in pharmaceutical manufacturing and/or laboratory environment is a strong asset.
- A great work environment with an inspiring work ambiance
- Growth and development possibilities
- An excellent benefits program starting day one
- Pension program after one year of service (company contribution of up to 10%)
- Tuition Reimbursements
- Service awards program
- If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
- The next step is a virtual conversation with the hiring manager
- The final step is a panel conversation with the extended team
Senoir Quality Assurance Specialist - Vaughan, Canada - Galderma
Description
Description
The Senior Quality Assurance Specialist is responsible to ensure that imported and distributed products by the Company meet the expectations and requirements of global and local policies and Health Canada regulations.
The Senior Quality Assurance Specialist works independently and provide direction to other QA team member to assist with all aspect of (cGMPs) including batch record review, batch disposition, new product introduction and supplier/ vendor management.
Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA) management, assessments for changes to processes, risk management, ensuring documentation and investigations meet all requirements.
Key Responsibilities
Skills & Qualifications
What we offer in return
Next Steps
Our people make a difference
At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.