- To contribute in establishing the aseptic process for Technology Transfer and complete the Commission & Qualification activities of the Aseptic area/ Equipment.
- Responsible to validate and establish the aseptic process as a Subject Matter Expert (SME) that includes aseptic process simulation and other related activities and tasks.
- Coordinating the collective efforts of other departments or outside contractors / Vendors to complete aseptic operation project tasks.
- Provides technical support in the process technology, implementation and scale-up. And to support feasibility studies with external stakeholders.
- Developing interpersonal capabilities in the areas of aseptic production and Providing training, support, and guidance to all team members of Aseptic production.
- Responsible for aseptic process validation and qualification activities by means of end-to-end validations such as from Change control, URS to PPQ.
- Responsible for complete Commissioning & Qualification activities of Aseptic production as per the regulatory needs and strive to reduce expenses and increase productivity.
- Authoring and Reviewing GMP documents of aseptic production department, such as qualification and validation protocols, summary reports and associated data for conformance to regulations and SOPs, but not limited to.
- Working with Aseptic production team effectively to achieve the strategic goals and objectives of the organization.
- Proactively support the quality management System elements of aseptic production departments such as deviation notifications, investigations, CAPA, change management and Risk assessments.
Qualifications & Experiences
- Bachelor of Pharmacy
- Minimum 10 Years of experience in Pharma/Biotech Manufacturing
- Business Results Oriented
- Excellent Leadership
- Excellent Team Development
- Expert Intercultural Sensitivity
- Highly Proactive and Expert in Acting with Urgency
- Excellent collaboration and Influencing
- Good command in English Language (Verbal and Written)
- Advanced in Aseptic filling process
- Good in Cartridge filling
- Advance in Washing & Sterilization
- Good in Commissioning & Qualification
- Expert in GMP Quality Management System