QA (Tpm) Specialist (Pharma/biotech) - Singapore - NUSANTARA PRIME CONSULTING PTE LTD

NUSANTARA PRIME CONSULTING PTE LTD
NUSANTARA PRIME CONSULTING PTE LTD
Verified Company
Singapore

2 weeks ago

Wei Jie

Posted by:

Wei Jie

beBee Recruiter
Description

Responsibilities:


  • Main contact person for the thirdparty manufacturing and oversee the TPM operation/process.
  • Responsible for implementing and maintaining the effectiveness of the Quality System.
  • Support to ensure that all quality goals are met, and all practices and procedures comply with company policies, GMP principles and applicable regulations for the quality areas.
  • Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
  • Manage TPM documents, quality agreement, FMEA, ASL and TPM scorecard/KPI.
  • Review, evaluate and approve all major deviations and determine the need for a corrective action. Document the deviation in the Trackwise system and perform product impact analyses.
  • Review, evaluate and approve all TPM change requests for process related, commodity, raw material, SCN, QC and facilities. Initiate global change in the Trackwise system.
  • Provide a constant review on the manufacturing process, equipment and facilities to assure compliance with procedures, specifications, and policies.
  • Write, review and approve annual product report/product quality report.
  • Actively involved in Precampaign activities, postcampaign review (Track & trending program)
  • Perform timely lot disposition in the SAP and LRMS/LotSmart system to meet shipment timeline and demands.
  • Prepare CoA, CoC and release package for drug substance.
  • Coordination of regulatory requests, including country submission, dossier review, GMP Renewal Program.

About You:


  • Bachelor Degree with at least 5 years' experiences in pharmaceutical or biotech facility preferably familiar with Quality Compliance, QA Thirdparty manufacturing oversight and/or QA Operations.
  • Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility
  • Relevant QA background from pharma or biotech environment is preferred
  • Familiar with Health Authorities standards (e.g., FDA CFR and EU)
  • Must be team player, meticulous, strong communication, analytical and organizational skills

Job Type:
Contract


Salary:
$5, $7,000.00 per month


Experience:

- pharmaceutical or biotech facility: 5 years (preferred)

  • Quality Compliance, QA Thirdparty manufacturing: 3 years (preferred)
- quality management system: 5 years (preferred)
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