Documentation Specialist Gmp

2 weeks ago

Singapore Novartis Full time

More than 380 That’s the number of associates in our Singapore Large Molecules division to support the making of medicines for our patients worldwide.
- The Documentation Specialist GMP reviews and consolidate the Batch records after production in order to deliver them to Quality Assurance acc. to set timelines & in right quality. The Documentation Specialist GMP performs entries and verifies transactions/declarations in the ERP system.**Key Responsibilities**
- Prepare, print and consolidate the batch documents, labels... and handover to production operators within the deadlines set according to the production schedule
- Follow up on updates and versions of documents in production (procedures and logbooks)
- Batch record system administration. Create and manage revisions of MBR in case of paper based records
- Ensure and coordinate the updating of production documents ( forms, SOPs, logbooks...)
- Manage the integration of CAPA (corrective and preventive actions) and actions related to change requests in the concerned documents
- Create new documents (Master batch records, forms, procedures, logbooks, etc.))
- Manage the documents review and approval cycle
- Ensure that the updated production documents are sent to the right population for “read and understand”. Ensure the archiving of production documents (road books, manufacturing forms, etc.)

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- Administration education, Technical education is desirable (Biology, Pharmaceutical Technology, Biotech) or equivalent job experience
- 1 to 3 years of relevant experience
- Proven experience with quality and compliance in an organization
- High level of conscientiousness and care (documentation, order and cleanliness in the workplace)
- Team player with strong team spirit
- Constructive way of working, flexibility, solution orientated, responsibility for your own work, understanding of quality
- Self-motivation and ability to learn
- Ability to work under pressure

**Why consider Novartis?**
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
- We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying**Imagine what you could do at Novartis**

**Division**
- Novartis Technical Operations**Business Unit**
- NTO Contract Manufacturing**Country**
- Singapore**Work Location**
- Singapore**Company/Legal Entity**
- NOV SINGAPORE PHARMA MANUFG**Functional Area**
- Technical Operations**Job Type**
- Full Time**Employment Type**
- Regular**Shift Work**
- No**Early Talent**
- Yes

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