Quality Assurance Operations Manager
We are seeking a skilled professional to manage key elements of our Quality Assurance (QA) operations. This role involves overseeing non-conformities, complaints, Corrective and Preventive Actions (CAPA), change control, risk management, documentation, and training.
Key Responsibilities
- Be responsible for manufacturing QA and shop floor quality assurance, including batch record review and PQR/APR.
- Ensure that compliance and performance processes are continuously measured and improved.
- Monitor Quality Metrics (Key Performance Indicators) accordingly.
- Lead inspection readiness activities and represent your department during inspections and customer audits.
- Manage the Compendial Compliance Process.
- Drive continuous improvement initiatives within your area of responsibility.
- Stay updated on industry trends, regulations, and evolving Health Authority expectations.
- Represent the Director of Quality in meetings as needed and when requested.
Requirements
- PhD or MSc in Pharmacy, Biology, Microbiology, or Chemistry.
- Demonstrated experience in Operations Quality Assurance.
- 5-10 years of experience in GMP-regulated environments.
- Proven experience in sterile drug product manufacturing is advantageous.
- Strong leadership skills with significant experience as a line manager.
- Passionate about performance, driving improvement and innovation.
- Highly self-motivated and results-oriented.
- Strong collaboration abilities and excellent communication skills across departments and functions.
- Analytical and logical thinker.
- Strong facilitation and organizational skills.
Benefits
- A dynamic work environment with ample career opportunities.
- A company culture that values personnel as individuals.
- Free parking and close access to public transportation within walking distance.
- Possibility of a partial home office arrangement, depending on the role.
Apply online using the form below. Please note that only applications matching the job profile will be considered.
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