QA Specialist

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Ready to contribute your expertise to the advancement of cutting-edge cancer treatments within a dynamic global environment?

If so, read on and apply today and be part of a mission-driven team that's shaping the future of cancer care.

My client is a prominent global biotechnology organization dedicated to groundbreaking cancer therapies. Their pioneering antibody-drug conjugate technology exploits the precision of antibodies to deliver potent agents directly to cancer cells, revolutionizing cancer treatment. With a strong product portfolio and a robust pipeline of innovative therapies, we aim to address critical unmet medical needs and enhance patient outcomes.

They are seeking a skilled individual to bolster their efforts in manufacturing and testing clinical and commercial GMP materials, primarily focusing on batch/lot review.

Key Responsibilities

• Oversee technical lot release procedures for clinical and commercial GMP Intermediates, APIs, and Drug Products to ensure timely dispositions.
• Collaborate with fellow team members, including QA Associates, to streamline release processes.
• Establish connections and partnerships with internal and external stakeholders like Supply Chain and CMOs, ensuring seamless release activities.
• Evaluate deviations during batch record review related to manufacturing processes when necessary.
• Facilitate the onboarding of new team members, providing specialized on-the-job training.
• Scrutinize executed batch production records to verify alignment with approved protocols, quality agreements, and GMP standards.
• Spearhead the CMO independent Batch Record Review certification initiative.
• Execute batch disposition from RSM to Bulk DP.
• Compile and manage comprehensive lot files.
• Lead and contribute to quality system enhancement projects.
• raft, revise, and endorse standard operating procedures and associated guidelines.
• Monitor local and global team meetings and project advancement to facilitate efficient communication regarding project status and concerns.
• Provide support to quality managers for intricate projects at CMOs, particularly those related to clinical lot production and demanding specialized resources for specific tasks.

Minimum Qualifications

• Bachelor's degree in a scientific discipline
• 3+ years of experience in the pharmaceutical industry
• Willingness to travel domestically and internationally, approximately 20% of the time.
• Relevant GMP experience, with a minimum of 2 years.
• Profound understanding of local compliance standards and ethical business practices.

Preferred Qualifications

• Familiarity with US/EU GMPs, ICH, and other pertinent international regulations.
• Experience in pharmaceutical production and testing (biologics or small molecules).
• Prior engagement with CMOs (Contract Manufacturing Organizations) is a plus.
• Exceptional communication skills and a proven track record of effective collaboration with internal and external teams.
• Familiarity with electronic documentation management systems is desirable.
• Capability to manage multiple tasks, prioritize assignments, and maintain a high standard of quality.
• Proficiency in English is mandatory; proficiency in additional languages is advantageous.

Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09

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