QC Method Validation Engineer-Pharma

at  PES International

Singapore, Southeast, Singapore -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate04 Jul, 2024Not Specified04 Apr, 202420 year(s) or aboveGood communication skillsNoNo
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Description:

PES is an international services company providing Project Management, Construction Management, Commissioning and qualification, and Automation services to our clients in the pharmaceutical, nutritional, and related sectors.
With offices across Europe, Asia, and the US, our core focus is on consistently delivering high-quality outcomes for our multinational clients.
This focus and our people’s experience in delivering consistent quality results for our clients over the past 20 years have been key to our success to date.
We are currently looking for QC Method Validation Engineer to join us on a permanent basis to help us deliver various projects in the Life Sciences Industry.

Key Attributes/Responsibilities:

  • Write analytical method validation protocols and reports
  • Review and approve lab results
  • Coördinate activities of lab technicians, and supervise lab experiments
  • Implement new and change existing lab methods in a controlled and documented manner
  • Lab methods transfer to new equipment, new laboratories, new sites in a controlled and documented manner
  • Reviewing documentation generated during development and laboratory processes, including protocols, assays/raw data, stability and validation reports.
  • Review and Approval of SOPs, protocols, reports or records.
  • Manage deviations/investigations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
  • Detect non-compliance with cGxP and Good Document Practice (GDP) requirements

Responsibilities:

  • Write analytical method validation protocols and reports
  • Review and approve lab results
  • Coördinate activities of lab technicians, and supervise lab experiments
  • Implement new and change existing lab methods in a controlled and documented manner
  • Lab methods transfer to new equipment, new laboratories, new sites in a controlled and documented manner
  • Reviewing documentation generated during development and laboratory processes, including protocols, assays/raw data, stability and validation reports.
  • Review and Approval of SOPs, protocols, reports or records.
  • Manage deviations/investigations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
  • Detect non-compliance with cGxP and Good Document Practice (GDP) requirement


REQUIREMENT SUMMARY

Min:20.0Max:25.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Singapore, Singapore