Transversal Projects Quality Assurance Specialist
vor 3 Wochen
About Haleon
Haleon is a world-leading consumer health company that is shaping the future of everyday health for billions of people. We are a unique combination of deep human understanding and trusted science, with a portfolio of category-leading brands such as Sensodyne, Voltaren, and Centrum.
About the Role
We are seeking a highly experienced QA representative expert to join our team as a Validation and Qualification Program Manager. As a key member of our team, you will be responsible for overseeing the validation and qualification activities for new equipment, new products, and transversal projects. You will ensure that all equipment, facilities, utilities, and processes used in the manufacturing of pharmaceutical products and API are prospectively qualified and validated prior to commercial distribution.
Key Responsibilities
- Develop and implement a comprehensive validation and qualification strategy for the site, in close collaboration with the Qualification/Validation team.
- Oversee the qualification activities for equipment, utilities, and facilities, including the approval of qualification documents and process validation activities.
- Ensure that all change, deviation, and CAPA records related to qualification and process/cleaning validation are in full compliance with internal requirements and regulatory guidelines.
- Provide coaching and support to other integrated QA end-to-end experts supporting qualification and validation activities.
Requirements
- Bachelor's degree in Sciences (Engineering or Life Sciences).
- Proficiency in English.
- Minimum 10 years of experience in the pharmaceutical industry or equivalent, with experience in managing a small team of experts.
- Mastery in the field of validation and qualification, with good knowledge of statistics and related regulations.
Preferred Qualifications
- Ability to demonstrate leadership.
- Expertise in the four areas of validation/qualification: equipment qualification, facilities-utilities qualification, process validation, and cleaning validation.
- Ability to demonstrate proficiency and thorough knowledge of applicable European and US legislations, health authorities, and/or industry groups.
About Haleon's Culture
Haleon is an inclusive environment that celebrates our unique perspectives, generates curiosity, and promotes fair and equitable outcomes for everyone. We strive to create a climate where we celebrate our diversity in all forms, treat each other with respect, listen to different viewpoints, support our communities, and create a workplace where your authentic self belongs and thrives.
Equal Opportunity Employer
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.
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