Technical Support
6 days ago
Prepare validation documentation (risk assessments, protocol validation, and reports) in alignment with the Validation Master Plan (VMP).
- Check and ensure proper alignment of all documents for manufacturing process validation, including production, packaging, cleaning, and monitoring.
- Support the execution of manufacturing and cleaning process validation activities, including sampling and physical parameter testing as per the established protocol.
- Escort validation processes across different shifts to ensure compliance with the validation protocol.
- Assist in document preparation for Strategic Projects, such as business cases, capacity assessments, redundancy projects, and cost-saving opportunities.
- Support dossier creation and provide regulatory documentation for optimal project and product development.
- Take responsibility for raw material selection and contribute to the technical execution of end-to-end activities in the respective portfolio focus.
- Commit to continuous self-training in professional matters and enhance communication and relationship skills.
- Propose and initiate development needs, updating progress through regular one-on-one performance-based dialogues.
**Specification**:
- Education: Pharmacist or Bachelor’s degree in Pharmacy, Chemical Engineering, or Chemistry preferred.
- Experience: 1-3 years in pharmaceutical manufacturing (fresh graduates welcome).
- Competencies:
- Good communication skills.
- Strong analytical thinking.
- Ability to work independently and in a team.
- Experience/knowledge in project management.
- Knowledge in statistics.
- Familiarity with GMP principles, regulations, production and packaging processes, stability, change management, and material/supplier qualification.
- Exposure to all manufacturing aspects, with emphasis on formulation development, technology and production, regulatory, and quality requirements.
**Job Types**: Full-time, Contract
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