Opportunity Description
Key Responsibilities:
- Support process-related projects including but not limited to Technology Transfer, Cleaning Validation (CV), Sterilization-in-Place (SIP) PQ, Process Qualification and Process Validation (PV) / Process Performance Qualification (PPQ).
- Draft Technology Transfer documentations such as facility fit assessment, control strategy, etc.
- Draft and review CQV and/or technology transfer deliverables including but not limited to risk assessment, technical justification / strategy / approach and qualification / validation protocols.
- Support CQV / PQ / PPQ activities.
- Support process comparability, resin lifecycle management, stability study and other process related activities.
- Hold Bachelor’s degree in Life Sciences, Engineering or related field.
- Have worked for at least 5 years in pharmaceutical, medical device or related environment.
- Have either pharmaceutical manuf...
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Submit your application for CQV / MSAT Engineer / Consultant (Pharmaceutical Process) at ORKA CONSULTING PARTNERS PTE. LTD.
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