We are looking for a Senior Manager of Quality Assurance with 4 to 6 years of experience, particularly in managing Quality Management System (QMS) documentation processes such as change control, deviations, CAPA (Corrective and Preventive Actions), OOS (Out of Specification), equipment qualifications, and validations. The ideal candidate should have a solid background in Chemistry, with excellent communication skills and the ability to ensure compliance with regulatory requirements.
Key Responsibilities
Overseeing and managing the QMS documentation lifecycle, including change control, deviations, CAPA, OOS, equipment qualifications, and validations.
Ensuring adherence to regulatory standards and guidelines in all QA activities.
Leading and participating in internal and external audits.
Developing and implementing quality assurance policies and procedures.
Providing guidance and support to cross-functional teams on quality-related matters.
Collaborating with regulatory affairs and other departments to maintain compliance with relevant standards.
Qualifications:
Bachelor's or Master's degree in Chemistry or related field (BSc/MSc Chemistry).
4 to 6 years of experience in Quality Assurance, preferably in a pharmaceutical or related industry.
Proven experience in managing QMS documentation processes, including change control, deviations, CAPA, OOS, equipment qualifications, and validations.
Robust knowledge of regulatory requirements and guidelines (e.g., FDA, EMA).
Excellent communication skills, both verbal and written.
Robust leadership and problem-solving abilities.