Regional QA Executive (Pharma/1 year contract)

People Profilers Pte Ltd| Date Posted: 11-Sep-2020
EA Licence No: 02C4944|EA Personal Registration No: R1111375
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Job Nature:
Permanent, Contract
Position Level:
Experienced
Qualification:
Diploma, Bachelor's / Honours

Job Description

PRINCIPAL ACCOUNTABILITIES:

  • Perform and provide support for the management of quality operations in responsible countries in Asia region to ensure its compliance with applicable local regulatory authority and the company’s global requirements for importation, local testing, repackaging, storage and distribution of the company’s products
  • Perform/support quality activities and resolve quality issues in responsible countries and/or region to support the continuous supply of commercial products in these countries in compliance to applicable local regulatory authority and the company’s global/release requirements
  • Provide support to ensure all relevant quality input/support are provided for all relevant post market activities in responsible countries are executed timely as per applicable local regulatory authority and the company’s global requirements so as to minimize interruption to supply of quality compliant product
  • Provide support to ensure all relevant quality input/support to business projects, new product introduction, product launches and product variation in responsible countries are provided in timely order
  • Provide support for quality oversight of relevant Contract Manufacturing Operation (CMO) in Asia region to ensure the relevant CMO activities are compliant as per applicable regulatory and global requirements. Provide support to ensure the products produced by the relevant CMO is compliant to applicable established and registered product specifications and requirements
  • Provide support for the management of all relevant regulatory inspections or certification audits for relevant CMO and responsible countries (CMO site inspection, GDP/GDPMD by regulators or certification body) to ensure successful maintenance / renewal of license and certification
  • Provide support for the development, implementation and maintenance of a fit for purpose regional QMS as per applicable to support Asia region and/or country quality operation/activities
  • Ensure that local operations, internal procedures and systems in use are in full compliance with the QMS, standards and policies, GDP, and regulatory requirements

REQUIREMENTS:

  • Tertiary qualification in Science or Engineering discipline or a Diploma with extensive experience in cGMP
  • 5 relevant years of experience in quality assurance and operations in pharmaceutical / medical devices industry with at least 2 to 4 years’ experience in GMP manufacturing and 2 to 4 years in Commercial Quality (GDP) environment
  • Experience in Audit, QA Batch Management. Regional Distribution Centre (RDC) QA operations, Complaints management, CAPA/RCA (Root Cause Analysis) management will be advantage
  • In depth knowledge of regulatory standards related to GMP, GDP – PIC/S, ICH, ISO 13485 and cold chain management.
  • Good sense of urgency and strong follow up
  • Able to work independently with stakeholders in Asia region and escalate issues as needed with good stakeholder management
  • Demonstrated interpersonal skills including strong negotiation skills
  • Excellent teamwork and coordination skills
  • 5 days week/1 year contract with full benefits
  • JOBID: X4648Y

All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.

 

Kindly email your resume in a detailed Word format to [Click Here to Email Your Resume]

 

We regret that only shortlisted candidates will be notified

 

People Profilers Pte Ltd

Tel:   6950 9753

EA Registration Number: R1111375

EA licence number 02C4944

EA Personnel: Lee Hui En Ashley

 

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People Profilers Pte Ltd