applications

Reports to: Quality Assurance (QA) Team Leader

Core Responsibilities:

• Play a key role in promoting and integrating quality into the business.

• Provide leadership by managing quality-related matters specific to the area of responsibility (API manufacturing operations). This includes mentoring and advising technical support and production personnel in deviation investigations, change proposals, qualification and validation.

• Execute the batch disposition process including ensuring that the manufacturing operation remains in a validated state and within regulatory commitments.

• Develop and maintain the quality systems necessary to ensure that the site is operating in full compliance with current Good Manufacturing Practices, standard operating procedures and sound scientific practice. This includes participation in local or corporate working groups, monitoring of internal quality standards and practices and external monitoring and benchmarking.

• Participate in the evaluation of third party vendors for raw materials, starting materials and packaging components including performing vendor audits.

Required Qualifications & Experience:

• A degree-level qualification in Chemistry, Biochemistry or a related discipline.

• Minimum of 5 years experience in a similar role in a regulated cGMP environment.