Quality and Compliance Associate - Mississauga, Canada - Seaford Pharmaceuticals Inc.

Description

Under the direction of the department manager, the Quality and Compliance Associate is responsible to carry out Quality Assurance functions at Seaford Pharmaceuticals to ensure compliance with all regulatory requirements applicable to Seaford's operations.

The Quality and Compliance Associate will provide oversight and guidance in matters of Quality and Compliance to Seaford employees, contractors, and suppliers, to support the achievement of company objectives.

• Participate in the development and maintenance of an effective Seaford Quality Management System that incorporates Good Manufacturing Practices (GMP) and quality risk management to ensure all regulated functions are performed and documented according to written procedures by appropriately trained and qualified personnel using suitable materials, equipment and facilities.
• Maintain an awareness of Regulatory requirements and changes affecting Seaford facility, products, and operations. Provide appropriate notice and direction to Seaford personnel on required actions to remain in compliance.
• Provide support to Seaford personnel in all matters related to Quality and Compliance. Promote GMP awareness through the administration of formal training, and through daytoday interactions and collaborative problem solving.
• Ensure that documents are created, compiled, and stored such that they form complete records, they are traceable to their source, their integrity is maintained, and they are readily retrievable whether in paper or electronic form.
• Participate in the management and execution of Quality System processes and procedures, including but not limited to: Product Disposition, Self Inspection, Training, Warehousing and Transport conditions, Retain Samples, Validation, Stability, Testing, Change Control, Complaints, Returns, Adverse Drug Reactions, Product Recall, Investigations, CAPA.
• Provide Quality oversight of internal procedures, processes, documents and record creation to ensure compliance with Regulations and Standard Operating Procedures.
• Provide oversight of Quality Control (procedures and records) for materials, components, and products throughout the supply chain.
• Participate in the oversight of outsourced activities to ensure those activities are performed and documented according to approved written procedures and GMP. This includes receipt and inspection of materials, components and finished product, review of records, followup to resolve discrepancies, auditing of facilities and procedures when required, participation in meetings, internal and external correspondence as required.
• Initiate action in a timely manner to document and address customer complaints, reported adverse drug reactions and any observed example of noncompliance with written procedures or GMP. Escalate issues to upper management for serious issues or when required to achieve resolution.
• Act as a Quality contact for Seaford Pharmaceuticals. Maintain correspondence with Regulatory Agencies, suppliers, and service providers regarding matters of quality and compliance. Participate in inspections and audits of Seaford facilities, systems and records, and coordinate responses to observations.
• Maintain an awareness of Quality trends and industry best practices.
• Track Quality measures and prepare periodic summaries to trend both internal and supplier performance.
• Assist with Regulatory duties as opportunity and workload demands.
• Perform other related duties as assigned.

• A minimum of a BSc degree
• 3+ years of QA/QC experience
• Quality auditing experience in pharmaceutical industry
• 2+ years of experience in batch review and release
• Knowledgeable of cGMP Canada, FDA, EU, ICH and other worldwide regulatory requirements
• Experience in dealing with Health Canada preferred
• Excellent oral and written English communication skills
• Proficient in Microsoft Office