Senior Documentation Specialist

4 weeks ago


Singapore PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD. Full time
Roles & Responsibilities

Job Description

  1. Personnel shall have good technical writing skills.
  2. Personnel shall be responsible for the development of engineering documentation like SOPs, quality standards, qualification protocols (e.g. URS, DQ, IQ, OQ, PQ etc.) for site with following of site QMS procedures.
  3. Personnel shall be familiar with cGMP practices required for pharmaceutical manufacturing industries.
  4. Personnel shall be familiar with the regulatory requirements (e.g. HSA, FDA etc.)
  5. Personnel shall be able to develop good documents by following PharmaGend applicable guidelines & procedures.
  6. Personnel shall be responsible for supporting the engineering operation including site new and retrofit projects related to manufacturing, utilities & facilities.
  7. Personnel should have the ability to handle project documentation and coordination.
  8. To assist on any ah-hoc duties that been assigned / task by the immediate superior.

Qualification

  1. Degree in Engineering with a minimum of 5 years of relevant experience.
Tell employers what skills you have

Microsoft Office
FDA
Microsoft Excel
Archiving
Technical Writing
Interpersonal Skills
Attention to Detail
Heavy Lifting
Banking
Team Player
Regulatory Requirements
Transcription
Manufacturing
Writing Skills
Checkpoint

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