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Description
The Biotechnologist role is responsible for the manufacture oftherapeutic proteins under cGMP conditions. Expectations for eachposition buil******** those describe******** the preceding level.
Equipment Expertise
- Learns an******** well-define********.
- Continue with ongoing training to increase knowledge an********.
- Attain a basic understanding of cGMP`s an******** in a GMPmanufacturing setting performing both supervise********unsupervise********.
- Equipment monitoring an********.
- Perform basic laboratory tasks (pH, Con******** sampling etc...)
- Perform routine sanitation tasks to maintain facility standards.
- Get trained & signe******** on 100% of CIP/ SIP/ basic tanko******** basic support instruments for area tasks.
- Demonstrate aseptic technique in the handling of produc********materials.
Technical Process Expertise
- Exhibit basic understanding of critical process parameters an********parameters.
Systems & cGMP Expertise
- Regular use of Standar******** Proce******** logbooks an********records.
- Ability to write clear & concise Event Comments with guidance.
- General understanding of the Lot Review process.
- Ability to be Lab Information Management System trained.
- Operating knowledge of Delta V or Control System.
- General understanding of the document change system. Initiate simpleDocument Change Forms, with supervision.
- General understanding of the deviation system.
- Traine******** locate an******** materials in SAP.
- Ability to order logbooks an********.
Problem Analysi******** Making
- Basic decision mak******** knows when to seek help an******** tocontact.
- Able to identify situations which may require escalation to supervisor(Event Comment, Dev******** Alarms).
Planning/Communication
- Organizes & plans assigne******** activities to ensure timelycompletion of assignments.
- Documents all work as it occurs.
- Participate in ensuring all dispensings an******** records are insuite in preparation for next 24 hours production.
Qualifications
- Degree in a relate******** or Engineering discipline
- Preferably with at least 1-5 years of relevant work experience in arelated (pharmaceutical / biomedical / medical device industry.
- Candidates from other industries who are keen to work in the pharmamanufacturing company, may apply
- Have positive team-oriente********
- Goo******** of cGMP
- Goo******** skills
- Willing to perform 12-hour shift duty