Senior Quality Assurance Validation Associate
2 days ago
We are seeking a highly skilled Senior Quality Assurance Validation Associate to join our team at BioVectra Inc. This is a permanent, full-time position located in a manufacturing facility.
Key Responsibilities- Manage policy and application of validation and qualification activities across all manufacturing locations, inclusive of equipment, computer systems, and process, and in accordance with current industry standard and good manufacturing practices (GMP).
- Interact with multiple departments and external stakeholders (including clients and consultants) and contribute to the leadership of the QS Validation Team.
- Provide guidance and oversight to the QS Validation team, including timesheets, vacation, employee performance review feedback and evaluation, and ensuring employees comply with GMP and safety training and requirements.
- Oversee validation and qualification program requirements across systems (equipment qualification, basis of design, design and controls assessment, computer systems, risk reviews, etc.) to ensure facility and site compliance.
- Manage the daily validation program requirements at all sites, including scheduling, and assigning tasks to the QA Validation Associates.
- Provide validation guidance, advice and support to management, project teams and external stakeholders (including clients and consultants).
- Determine, track, and assess key performance indicators for the QS Validation team and implement continuous improvement measurements based on results.
- Demonstrate the ability to understand complex quality issues and drive scientifically sound compliant resolutions.
- Multi-disciplinary project management, including schedule preparation, planning, directing, presenting, and managing designated projects.
- Lead quality investigations, including working with cross-functional teams to identify root causes, developing corrective actions, creating investigation summary reports and presenting findings to stakeholders.
- Participate in the budgetary process for the Quality Unit.
- Contribute to the leadership of the Quality Unit as a member of the Quality Systems Leadership Team.
- Review existing systems for gaps related to validation, develop solutions and propose / implement strategies to mitigate the risks.
- Participate in external audits and lead internal audits.
- Research, develop and implement program policy improvements for the validation programs.
- Monitor and enforce GMP requirements during day-to-day operations for all departments within the company.
- Bachelor degree in a scientific, engineering or pharmaceutical manufacturing field.
- Five years' experience with a food or drug manufacturing company, preferable in a Quality Unit position.
- Three years' validation and qualification experience.
- Previous leadership experience is an asset.
- Certified Quality Engineer is an asset.
- Travel between locations is required.
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Windsor, Ontario, Canada BioVectra Inc. Full timeSenior Quality Assurance Validation Associate BIOVECTRA Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents. We are seeking a highly skilled Senior Quality Assurance Validation Associate to...
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Senior Quality Assurance Associate
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Windsor, Ontario, Canada BioVectra Inc. Full timeSenior Quality Assurance Associate Windsor, NS, Canada Req #1601 Sunday, August 4, BIOVECTRA Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents. BIOVECTRA has an opening for Senior...
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Senior Quality Assurance Associate
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