Monitoring the performance of the Quality Management System (QMS), producing data, and measuring quality operations against the set standards.
Coordinating and supervising activities required to meet quality standards.
Liaising with other departments throughout the organization to ensure that the Quality Management System (QMS) is functioning properly.
Leading the preparation for audits from external parties and conducting the audit, coordinating the response, and following up to ensure that the CAPA plan is carried out within the specified timescales.
Leading the preparation for regulatory inspections, working with other relevant staff to prepare the response and ensure the on-time closure of applicable CAPA plans.
Planning and performing internal audits of the processes and providing formal written feedback to include guidance on corrective and preventive actions (CAPA) to address any non-compliance with procedures and/or regulations.
Conducting external audits, e.g., third-party service providers, to assess the quality of work, identify potential risks, and support vendor selection.
Developing, reviewing, and implementing SOPs, as required.
Requirements
PharmD or a Master's degree in Chemistry, or similar fields.
At least 3 years of supervisory experience in quality assurance in the pharmaceutical industry.
Fluent in English.
Excellent organizational skills and attention to detail.
Excellent time management skills with a proven ability to meet deadlines.
Excellent verbal and written communication skills.
Strong analytical and problem-solving skills.
Proficient with Microsoft Office or related software.
