Quality Assurance Head
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
Employer questions
- What's your expected monthly basic salary?
- Which of the following types of qualifications do you have?
- Have you worked in a role where you were responsible for authoring and reviewing technical documentation?
- How many years' experience do you have as a Head of Quality Assurance?
- Do you have technical writing experience?
- How many years of auditing experience do you have?
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