Senior TA Specialist of the Bioconjugate Leader
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Responsibilities
Accountable for solution (Buffers and Media) preparation for drug substance manufacturing according to GMP.
Accountable for cleaning and component sterilization of production equipment and facilities for drug substance manufacturing according to GMP.
Participate in the validation of solution preparation, cleaning and component sterilization of production equipment and facilities.
Participate and execute production projects and completing production plans on time.
Ensure accurate and timely documentation records in accordance with GMP requirements.
Assist in drafting/reviewing/revising SOPs, URS, PQ, MBR and other documents.
Participate in continuous improvement program
Lead deviations and change control management.
Participate and support all internal and external audits.
Good collaboration across functionally and perform other tasks as assigned by leadership.
Requirements
Degree in Biological, Chemical, Pharmaceutical Engineering, or other related specialties; minimum 5 years’ experience or candidates with equivalent work experience will also be considered.
Ability to adapt to a GMP cleanroom environment, including the requirement to perform gowning and degowning.
Possess good communication and comprehension ability.
Display good working attitude, strong work ethic, and team collaboration.
Able to perform shift work
Be open to accepting temporary work assignments, including overtime, and other roles as required.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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