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Technical Support

4 weeks ago

Depok, Indonesia PT SWAKARYA INSAN MANDIRI BOGOR DEPOK DAN BEKASI Full time

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