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.