Quality Assurance Manager (Biopharma/CBD/1 Year Contract)
Role Purpose:
The Responsible Person, Quality Assurance Manager Australia and New Zealand, will work collaboratively with relevant stakeholders to implement & maintain the local Australian and New Zealand QMS and will work with internal & external stakeholders to ensure quality requirements are met for organisation products, throughout the distribution network, and within Australia and New Zealand, all the way to patients.
Key Responsibilities:
- Establishes and maintains the Quality Management System in Australia and New Zealand to ensure that it meets local regulatory and industry standards and organisation expectations.
- Support maintenance of relevant licenses.
- Manages local process of change control, deviation, CAPA, complaint management and supplier management.
- Manages local Quality Management Review process.
- Participates in organisation’s Quality Escalation process for critical quality issues, and regulatory compliance issues.
- Ensures up to date organograms, training curricula pertaining to GMP/GDP, training records, CVs, and Job Descriptions are in place for local affiliate personnel working on quality/distribution matters.
- Establishes and maintains the Affiliate Quality Manual and GMP/GDP procedural documents.
- Establishes and maintains the Quality Agreement with 3PL/4PL and local GMP/GDP related suppliers/service providers, as required.
- Reviews Annual Product Quality Reports (if applicable)
- Ensures shipping conditions match the product license/product label particulars and transporters are appropriately qualified.
- Ensures premises and/or equipment used are reviewed regularly to ensure they are adequate to allow the handling, storage, and distribution of medicinal products in a manner that ensures the maintenance of product quality.
- Supports Customer Services with enquiries of a GDP nature such as delivery issues, transportation conditions, disputes, etc.
- Working with 3PL/4PL, provides guidance on supply related issues.
- Arranges authorized relabeling/repackaging in cooperation with 3PL/4PL (where applicable)
- Supports the management of quality and distribution complaints.
- Supports the investigation of fraudulent and counterfeit medicinal products.
- Manages product return and destruction.
- Manages local recalls and participating in supplier’s recall challenge or perform local mock recall, as needed.
- Qualifies and manages local 3PL/4PL and supports audit of 3PL/4PL.
- Qualifies and manages local GMP/GDP related suppliers/service providers, auditing and approving these according to local requirements.
- Assure customers validations and adequate records compliance to organisation QA requirements are established and maintained for all local distributors/customers.
- Collaborates with RA to support inspections and audits.
- Manages the Affiliate self-inspection program.
- Supports audit of distributor (where applicable).
- Collaborates with RA to implement activities for new product launch and product life cycle management.
Knowledge, Experience & Skills:
- Highly organized individual with a strong work ethic and ability to work flexibility and independently.
- Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Distribution Practices (GDPs) and knowledgeable about the specific requirements for Australia and New Zealand.
- Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
- Demonstrates proficiency in Quality Systems processes (Deviation, CAPA, Change Control, Complaints, etc.)
- Demonstrates a knowledge of regional/local regulatory requirements and industry standards.
- Demonstrates strong verbal, written, and interpersonal skills in English.
- Demonstrates proficiency in Microsoft Office applications, particularly, WORD, Excel, PowerPoint, and Teams. Familiarity with technology platforms such as Veeva Vault, SAP ERP, etc.
- Working knowledge of Risk Management tools (e.g., Failure Mode Effects Analysis (FMEA) is preferred.
Typical Educational Experience & Competencies
- Bachelors’ degree and 7+ years of relevant experience in a GMP or GDP environment-related field
- Masters’ degree and 5+ years of relevant experience in a GMP or GDP environment related field.
- Ability to work on own initiative as well as display strong teamwork skills.
- Demonstrates clear personal responsibility for own work, in terms of both the quality of the work and the manner in which it is performed. ‘
- Ability to support change and respond to change requirements by continually striving to improve working processes and systems, consistent with the organisational strategy.
EA License No. 01C4394 • RCB No. 200007268E •EA Registration No. R22109454 Malcolm Lee Jun Hao
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