POSITION SUMMARY
This role involves overseeing internal and supplier audits while driving quality initiatives like change control and risk management. The individual will work cross-functionally, acting as a technical point of contact for quality-related matters, and will represent the Quality Department during regulatory inspections and client audits. Responsibilities also include reviewing and approving change control projects, creating implementation plans, and updating Standard Operating Procedures (SOPs) to reflect process improvements and changes.
The position is key in analyzing quality data to proactively address potential issues, reduce waste, and ensure continuous improvement in product quality. By leading efforts in compliance, risk management, and regulatory standards, this role supports our mission to provide access to high-quality, affordable medications.
DUTIES AND RESPONSIBILITIES
- Lead the implementation and improvement of Quality Systems in line with company objectives.
- Manage and participate in internal audits, supplier audits, CAPA processes, nonconformance investigations, Quality Management Reviews, document control, change control, risk management, and training initiatives.
- Establish and maintain a continuous improvement program for quality systems.
- Assist in training employees on good documentation practices, GMP standards, and other quality-related topics.
- Represent the Quality Department in regulatory inspections, client audits, and cross-functional meetings.
- Review and approve change control projects and improvement programs.
- Write, review, and revise SOPs and related documentation to reflect changes and improvements.
- Analyze quality resources to identify potential risks and ensure the continuous enhancement of product quality.
- Compile and report key performance indicators, metrics, and the compliance status of Quality Systems for management review.
- Conduct internal audits.
- Provide exceptional customer service to internal and external stakeholders, fostering a culture of GMP compliance.
KNOWLEDGE AND SKILLS
- Experience in sterile aseptic manufacturing processes.
- Skilled in continuous process improvement methodologies (e.g., Six Sigma, Lean Manufacturing).
Interested candidates are invited to submit their resume and cover letter and expect to hear back as soon as possible!
