About this role
- Management of a team responsible for QA, development management and annual assessments of the members of the team in charge.
- Train new employees in policies and procedures related to their quality / GxP functions.
- Ensure the conditions for the authorization to market products are maintained throughout the product life cycle.
- Ensure adequate quality systems are in place and maintained in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Distribution Practices (BPD).
- Manage the supplier qualification program for applicable suppliers.
- Perform supplier quality checks according to an approved schedule.
- Ensure that a valid and robust QA system is in place to deal with complaints about product quality.
- Strategic and operational contribution to the Quality Manual; develop a quality plan
- Develop and manage the budget for quality activities and ensure monitoring.
- Interact with the regulatory affairs, quality and compliance department on strategic decisions serving the quality assurance department.
- Participate in discussions with various regulatory agencies; ensuring a direct link e.g. to answer questions from regulatory submissions (chemistry and manufacturing file); for Good Manufacturing Practices (GMP) inspections and all aspects of quality.
- Ensure company policies and procedures reflect the standards required by regulatory authorities
- Ensure that management and employees have the appropriate information to ensure continued compliance with regulatory requirements from authorities in the United States and Canada and other jurisdictions as required.
- Up to date on all regulations of the United States, Health Canada, European Medicines Agency, and other countries served by the products.
- Act as the main representative of the quality service on the various committees including the Quality management review committee
- Directs and supervises logistics, financial, contractual and project management activities related to quality assurance.
- Ensure compliance and quality requirements are met; Implements corrective measures as required.
- Ensure open communication on operational issues with other departments (e.g. Regulatory Affairs, Supply, Distribution and Pharmaceutical Development) regarding timelines and QA needs.
- Ensure proper identification, selection and supervision as well as direct communication with suppliers.
- Evaluate and ensure the disposal of the returned product.
- Where applicable, provides QA support and feedback to other groups in the Medical Department, Department of Regulatory Affairs, Quality and Compliance as well as other departments.
- Prepare presentations to communicate information to management.
- Monitoring project management for QA.
- Responsible for certification and release of batches in the United States and Canada, and support for batch release in Europe.
- Ensure that deviations, investigations and other quality issues are investigated and duly resolved.
- Evaluate incidents and take preventive and corrective action
- Create and evaluate specifications and acceptability criteria for our products.
- Ensure the manufacturing, packaging and analysis of the product are defined, controlled and in accordance with Good Manufacturing Practices (GMP).
- Review the stability data and approve the new test or expiration date.
- Qualify service providers: inspect their installations; identify and recommend corrective and preventive actions.
- Draft and negotiate quality agreements with the various external partners.
- Evaluate the quality of the finished product and decide to retain the lots or release them for distribution.
- Ensure all stages of GMP are respected and comply with Canadian, American and European regulations and directives in the event.
- Participate in the evaluation of complaints in order to determine the causes and recommend corrective and preventive actions.
- Facilitate the conduct of audits and perform internal and external audits, as well as the concern and responsibility that corrective actions are taken to follow up on audit observations.
- Review and approve documents, specifications, procedures, labels, packaging products, master files for manufacturing (main batch records) and packaging, protocols, validation reports, deviations.
- Check the temperature data during the transport of the products and decide on their status / disposition.
- Determine the disposition of the non-conforming product.
- Establish and maintain a change control system.
- Review production documentation and investigations for customer complaints related to the manufacturing and packaging of the product.
- Analyze statistical data on complaints and deviations recommend actions
- Write procedures, specifications, explanations, preventive and corrective actions, change requests.
- Review and approve the annual product quality review.
- Review and approve the documentation of our suppliers related to our products at the quality assurance level.
- Produce forms, memos, lists and reports to document everything that needs to be quality assurance.
- Ensure the integrity of the documentation and quality data for submission (s) to regulatory agencies.
- Bachelor of Science or equivalent (e.g. BAC in pharmacy, chemistry, biology or chemical engineering).
- Specific training in quality assurance.
- 7 to 10 years of relevant experience in a quality assurance role in the pharmaceutical or biotechnology industry, ideally with sterile products.
- 5 to 10 years of experience in team management.
- Current experience of having carried out audits / inspections.
- Excellent knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (BPD), and good knowledge of directives / laws / regulations of the International Council for Harmonization (ICH).
- Excellent communicator and well organized with superior presentation skills.
- Excellent QA management expertise and proportional experience in regulatory authority inspections.
- Knowledge of new drug registrations and approvals and excellent representation with regulatory authorities in the United States (FDA), Canada (Health Canada) in Europe (European Medicines Agency) or other countries, in relation to insurance quality and chemistry and manufacturing regulatory records.
- Understand the quality mechanisms for releasing batches of manufactured drugs.
- Knowledge of medical instruments would be an asset.
- Knowledge of Word, Excel, Power Point and Outlook and Project software.
- QA problem solving and ability to generate ideas and identify potential solutions
- Spirit of synthesis and analysis
- Ability to manage and train staff
- Ability to negotiate and ability to influence others
- Able to establish priorities
- Ability to multi-task
- Ability to learn quickly and be curious and resourceful
- Able to manage and control stress in the workplace
- Proficiency in written and oral expression (English and French)
- Availability for occasional business trips
What we offer
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
- Vacancy number: PUB255467
- Location: Montreal
- Market: Life Sciences & Health Care
- hours per week: 40
- Branch: Pharmaceutical
- Education level: Academic Bachelor
- Area of Expertise: Research & Development
- Closing date: Friday, April 10, 2020
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