Quality Assurance Head

3 days ago

Manila, National Capital Region, Philippines BioAnalytica Inc. Full time ₱900,000 - ₱1,200,000 per year

Company Overview

Established in January 2019, BioAnalytica Inc. is a testing laboratory performing bioanalytical laboratory services to local and international clients dedicated in ensuring quality, safe and reliable drugs for the pharmaceutical industry.

Job description:

· Documentation of the laboratory's quality manual, in accordance to the requirements of ISO/IEC 17025:2017

· Identification, investigation, and resolution of nonconforming work

· Conduct and Participation in internal audits

· Conduct and Participation in management reviews

· Review of Method Validation or Method verification protocol prior to approval and use by the Laboratory.

· Review of Method Validation/Verification reports. Analysis reports, and Certificate of Analysis prior to authorization for release.

· Act as Document controller

· Manages Customer feedback and complaints related to quality and working to resolve issues to enhance customer satisfaction.

Requirements:

· Comprehensive knowledge in ISO/IEC 17025:2017 and OECD Good Laboratory Practices

· Must be a Registered Chemist/Pharmacist with extensive knowledge in HPLC

· At least 1-2 years of experience in Quality Assurance

· Awareness of internal audits as per ISO/IEC 17025:2017 standard, whether participating as an auditor, or an auditee

· Experience in technical documentation, particularly writing procedures, instructions and manuals

Secondary Qualifications:

o Awareness of the ISO/IEC 19011:2018 is a plus

o Awareness on information security

o Knowledge on data privacy as relevant to the data privacy act

o Awareness of ISO/IEC 27001 is a plus

o Awareness of Good Manufacturing Practice is a plus

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