LP
Senior System Testing / QA Specialist – Healthcare
LinkedIn Recruiter Post
Senior QA Specialist needed for healthcare tech modernization in GTA. Contract role, hybrid, $60 - $75/hr.
About the role
- Coordinates inspections and sampling of incoming raw materials for pharmaceutical company Apotex. Ensures compliance with GMP and manages quality assurance procedures.
Responsibilities
- Responsible for ensuring that all incoming raw materials, packaging components and packaged products are inspected and sampled in accordance with Good Manufacturing Practices and established Standard Operating Procedures
- Responsible for coordinating, with the Supervisor Logistics, training, monitoring and auditing of the receiving sampling and inspection activities performed by Samplers/Material Handlers
- Responsible to ensure that deviations or non-conformances are adequately investigated and documented in order to provide appropriate disposition of materials
- Works in a safe manner collaborating as a team member to achieve all outcomes
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies
- Have required working knowledge to operate SAP, LIMS, and Trackwise systems
- Lead investigations and CAPA implementations within the QAIP department and provide support to investigations and implementation of CAPAs to all areas of the business as required
- Review and approve all non-conformances and assist Logistics personnel with troubleshooting/investigating issues related to the material receiving process, sampling process and NIR or TruScan analysis as required
- Generate investigations as an observing department when deviations from established procedures or acceptance criteria are observed
- Audit the work performed by Samplers/Material Handlers during receipt and inspection of incoming material, sampling of material and completion of NIR or TruScan analysis
- Review and update the manufacturing plant entry in SAP in accordance with manufacturer Certificate of Analysis
- Notify Supplier Quality/Procurement departments to update SAP Master Data (i.e. Material Storage Condition) when discrepancy is observed during the material receiving process
- Oversees the daily operations of the QAIP Sampling area and Production to ensure rooms and equipment, are used in accordance with GMP and Standard Operating Procedures
- Performs reserve sample inspections and waste disposal as required
- Log in samples into SAP/LIMS and forward the documents/material samples to required labs for testing
- Initiate Change Control for changes related to QAIP process as required
- Ensure that training records are accurate and completed according to cGMP
- Provides training to new Coordinators
- All other relevant duties as assigned.
Requirements
- Bachelor of Science Degree from a recognized educational institution in a related field or Community College diploma in a related field
- Must be familiar and knowledgeable with GMP and quality requirements
- Excellent English written and verbal communication skills
- Good organizational skills and ability to manage time effectively
- Must be detail-oriented, accurate and reliable
- Must be able to work independently with minimal supervision
- Proven analytical and problem solving skills
- Ability to manage multiple priorities in a fast-paced and changing environment
- Familiarity with Word, Excel, Access would be an asset
- Minimum one year of relevant experience in a pharmaceutical environment with a Bachelor of Science Degree
- Minimum of three years of relevant experience in a pharmaceutical environment with a Community College Diploma
Benefits
- At Apotex, we are committed to fostering a welcoming and accessible work environment
- Accommodation for applicants with disabilities as part of the recruitment process
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