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Senior Quality Assurance Validation Associate
2 months ago
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 join our team in Windsor, NS. This is a permanent, full-time position that offers a competitive salary and benefit package.
The Senior Quality Assurance Validation Associate will be responsible for managing policy and application of validation and qualification activities across all BIOVECTRA manufacturing locations, inclusive of equipment, computer systems, and process, and in accordance with current industry standard and good manufacturing practices (GMP).
Key Responsibilities:
- Provide guidance and oversight to the QS Validation team, ensuring employees comply with GMP and safety training and requirements.
- Oversee validation and qualification program requirements across systems, ensuring 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.
- Determine, track, and assess key performance indicators for the QS Validation team and implement continuous improvement measurements based on results.
- Drive scientifically sound compliant resolutions for complex quality issues.
- Lead quality investigations, working with cross-functional teams to identify root causes, develop corrective actions, and present 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 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.
Requirements:
- Bachelor's degree in a scientific, engineering, or pharmaceutical manufacturing field.
- Five years' experience with a food or drug manufacturing company, preferably in a Quality Unit position.
- Three years' validation and qualification experience.
- Previous leadership experience is an asset.
- Certified Quality Engineer is an asset.
BIOVECTRA is committed to creating an inclusive environment and building a team that represents a variety of backgrounds, perspectives, and skills. We value diversity and recognize that experience comes in many forms and skills are transferable.
We thank all interested parties for their interest in this opportunity. Only those applicants considered for an interview will be contacted.
