Career Connections Canada Inc.
'Connecting great people with great companies'
What we offer:
- A safe and clean; GMP regulated work environment
- Opportunities for career growth and development
- A competitive wage/salary
- Incentive bonus programs that are designed to reward employees for their individual contributions
- Benefit programs designed to support our employees and their families, including a comprehensive health & dental benefits package, group RRSP matching program, direct access to healthcare and well-being programs, and paid time off
- Employee training and organizational development programs including tuition reimbursement, internal mobility programs, and employee recognition programs
Our Brampton location is presently looking for a Senior Associate, Quality Compliance (QA) to join our QA department.
The main responsibility for this position is to manage on a daily basis, the Customer Quality Management Program and Vendor Quality Management Program.
This position will foster strong relationships with key Pharma customers, Private Label customers, Vendors (raw materials, packaging components, third party logistics and GMP Services) in order to liaise between internal customers and manage all requests to identify, assess and address all quality risk activities and processes according to regulatory guidelines and Standard Operating Procedures.
Principal Duties and Responsibilities :
- Foster strong relationships with key Pharma and/or Private Label customers and Vendors
- Ability to provide feedback to Pharma and Private Label customers and Vendors concerning all quality systems, change control notifications, product environments and laboratory results.
- Foster strong relationships with key internal customers (Research and Development, Regulatory Affairs, Materials Management, Pharmaceutical Technology)
- Maintain a strong quality presence in the organization to demonstrate a proactive approach to first time quality.
- Ensure compliance to responsibilities outlined in executed Quality Agreements
- Prepare and maintain Quality Agreements.
- Respond to customer and vendor queries and notifications within the scope of the quality agreement or SOP
- Onboarding of new contract manufacturers and the maintenance of approved contract manufacturers through processing, review and assessment of change controls, specifications, master documents and quality agreements
- Lead and/or Participate in Recall activities
- Lead and/or Participate in Continuous Improvement projects
- Participate in and/or lead Non Conformance Investigations as related to Customers or Vendors.
- Perform risk assessments (as needed) for material/component/vendor related issues
- Evaluate Vendor performance to determine initial approval and continued status.
- Perform certification of Vendors, materials, components and contract manufacturers.
- Perform audits of Vendors and contract manufacturers (where applicable)
- Assist in reporting metrics for Quality Compliance department.
- Maintenance of databases, documents and Approved Vendor Lists (AVLs)
- Ensure compliance to all Quality Management Systems (Training, Corrective and Preventative Actions, Documentation, Change Control)
- Participate in Internal, Customer and Regulatory Audits.
- Lead/Train Associates in Compliance related activities.
- Develop and revise SOPs
- Member of the Vendor Review Board (VRB)
- Other duties as assigned
Knowledge, Skills and Abilities
- Minimum of B.Sc Chemistry or other associated discipline
- 5 – 7 years experience in quality assurance/quality compliance experience in the pharmaceutical or related industry environment (creams, gels and ointments)
- Bilingual (French and English) capabilities is an asset
- Proficient in quality systems such as change control, investigations, documentation, batch review and release.
- Complete knowledge of pharmaceutical operations/standards combined with a strong quality mindset.
- Good organizational skills, detail oriented and multi-tasking ability combined with strong attention to detail
- Excellent written and verbal communication skills with ability to articulate messages and interact with a variety of audiences (internal and external)
- Excellent technical writing skills
- Proven negotiation and training skills in ensuring quality standards are maintained while also meeting business expectations.
- Knowledge of applicable software
- Knowledgeable of pharmaceutical operations
- Knowledgeable of GMP, FDA and HPFBI requirements
- Ability to manage internal and external requirements
- Strong problem solving skills with ability recommend and implement strategies towards enhancing the quality standards of the department and facility
- Evaluation of customer’s requests without divulging company confidential information
- Generally pleasant surroundings working in an office environment. Fairly level temperatures. Occasional work in other areas (compounding, warehouse, etc.) as required.
***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc.