Senior Specialist

Senior Specialist - Quality Hypercare (Biosimilars QC)
The Senior Specialist, Biosimilars at ADVANZ PHARMA will provide technical support to the Associate Director, Biosimilar Quality on all aspects of biological products and the development and enhancement of the Pharmaceutical Quality System to ensure it meets Health Authority expectations. The portfolio will consist of a range of products including in-licensed and development projects. This role will involve exposure to management across the business and requires an individual with a dynamic and collaborative approach.Responsibilities include maintaining the Pharmaceutical Quality System to ensure it remains fit for purpose with respect to Biologics/Biosimilar products, supporting the assessment of new pipeline products, ensuring on-time delivery and launch of all pipeline projects, identifying and resolving potential Quality risks, participating in interactions with Competent Authorities, preparing for Quality Review Meetings, providing QA oversight of analytical method development and validation, reviewing protocols and reports, collaborating with external testing partners, acting as subject matter expert in the review of Quality System records, incidents, and changes, performing lot disposition process, change control assessments, approving Deviations and CAPAs, conducting risk assessments, and embodying company core values.Qualifications required for this role include a tertiary qualification in any discipline within Life sciences or Pharmaceuticals along with professional qualifications. Desired knowledge, skills, and experience include being a subject matter expert in quality assurance of Biosimilars, experience in biopharmaceutical active substance production and analytics, working with Biologic and Biosimilar applications, interacting with EU regulatory authorities, knowledge of European regulatory guidelines, early development and validation programs for Biosimilars, strong people management skills, ability to operate within tight deadlines, clear communication skills, positive and can-do approach, learning agility, scalability, and ability to work collaboratively.ADVANZ PHARMA offers an empowering and inclusive work environment where employees are encouraged to be entrepreneurs and embrace challenges for personal and company growth. The company values integrity, rewards outcomes and impact, and promotes diversity and gender equality. Flexible and agile working options, competitive salary, benefits package, and opportunities for recognition and career progression are provided. If you are a highly motivated individual passionate about making a meaningful difference to patients" lives, and possess the required qualifications and skills, join ADVANZ PHARMA on their exciting journey by applying now with your CV and Cover letter.,
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Senior Specialist - Quality Hypercare (Biosimilars QC)
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