This function is responsible for supporting the daily manufacturing and facility operations. Functions include discrepancy resolution, document review, training program support, batch record review, and project management. This function partners with manufacturing to identify resolution to events in consultation with Quality Management. The position will support completing tasks, resolving problems and making recommendations using sound judgment and scientific rationale on areas of diverse scope.
Applies knowledge of regulations and industry practices to drive new policies, procedures, and guidelines in consultation with management. Executes most routine activities without supervision. Able to contribute to risk based decision process. Understands the wider impact and regulatory implications of decisions made.
Effectively organizes, facilitates and chairs meetings. Listens effectively to the relevant stakeholders and consistently looks for ways to improve team dynamic and support given to the business management and audit inspectors. Can defend quality decisions by communication the "whys" for the decision making process.
- Authority to approve written procedures and other documents
- Develop Standard Operating Procedures and other quality related documents.
- Evaluation of batch manufacturing records and testing records
- Interact with plant personnel to ensure CGMP compliance.
- Support manufacturing in the writing and approval of discrepancy reports
- Support Change Control process by providing Quality Assessment based on impact to product or processes
- Provide manufacturing line support by providing quality support to projects by ensuring cGMP adherence.
Skills / Abilities:
- Working knowledge of US Drug Product GMP requirements and associated guidelines.
- Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
- Ability to increase others knowledge of US end European GMP regulations and guidance.
- Strong written and oral communication skills.
- Experience in administration of quality systems for drug product manufacturing and quality control operations.
- Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
- Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others
- Good team player with a can-do attitude and dependable.
- Can get things done on the basis of influence.
- Can work in a fast-paced environment with a sense of urgency and the ability to handle multiple issues.
- Attention to detail.
- Identifies opportunities to improve and contributes to problem solving.
- Requires a Bachelor’s degree in a scientific discipline or equivalent with a minimum of 3 years experience in a Quality Assurance role or a high school diploma with a minimum of 5 years experienced in a Quality Assurance role.
Alkermes, Inc. - 20 months ago