Solution Preparation Manager
1 week ago
Responsibilities
· Provide leadership, coaching and training to the team.
· Accountable for team development and performance review.
· Accountable for solution (Buffers and Media) preparation for drug substance manufacturing according to GMP.
· Accountable for the validation of solution preparation, cleaning and component sterilization of production equipment and facilities.
· Accountable for execution of production projects and completing production plans on time.
· Accountable for team's accurate and timely documentation records in accordance with GMP requirements.
· Manage human and material resources to meet production targets
· Lead in drafting/reviewing/revising SOPs, URS, PQ protocol, MBR and other documents
· Lead and drive continuous improvement program.
· Lead and support all internal and external audits.
· Accountable for deviations and change control management.
· Strong collaboration across functionally and perform other tasks as assigned by leadership.
Requirements
● Degree in Biological, Chemical, Pharmaceutical Engineering, or other related specialties; minimum 10 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 strong communication and comprehension ability.
● Display strong working attitude, strong work ethic, and team collaboration.
● Be flexible and ready to work shift on need basis
● Be open to accepting temporary work assignments and other roles as required.
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