Summary
Overview
Work History
Education
Skills
Hobbies and Interests
References
Affiliations
Timeline
Generic

Carole Wrench

Emerald,AU

Summary

Quality Assurance Manager with proven success at QSM Group, achieving 96% in SQF Food Safety Audit. Expertise in GMP and HACCP ensures compliance and effective training programs. Leadership and communication skills enhance team performance and drive operational excellence.

Overview

38
38
years of professional experience

Work History

Quality Assurance Manager

QSM Group (t/a Food-Pak)
Dandenong South, VIC
05.2025 - Current
  • Achieved SQF Food Safety Audit Version 9 rating of 96 Excellent in August 2025.
  • Implemented GMP training for all staff according to established schedule.
  • Conducted internal audits following annual audit schedule mandated by SQF Version 9.
  • Developed and introduced standard operating procedures, forms, and work instructions for operational processes.
  • Trained operators on newly implemented processes to ensure compliance and efficiency.
  • Maintained adherence to food safety standards as a WQA, Coles, and SQF certified facility.

Quality Assurance Manager

IXOM (ABP – Hallam)
Hallam, VIC
11.2022 - 05.2025
  • Implemented procedures to ensure compliance with Pharmaceutical Quality Systems according to TGA, HACCP, ACO, and Kosher standards.
  • Maintained up-to-date knowledge of quality requirements and communicated amendments to relevant staff.
  • Assisted in developing QA staff's understanding of TGA, PIC/S guidelines, and FSANZ legislation for essential oils.
  • Hosted regulatory audits from TGA, ACO, HACCP Australia, Kosher Australia, and various customers.
  • Conducted internal audits as per the annual schedule mandated by TGA, HACCP, ACO, and Kosher standards.
  • Supported QA staff in environmental monitoring and provided feedback based on evaluation results.
  • Delivered GMP training to all staff according to the annual training schedule to ensure compliance.
  • Developed training modules and conducted assessments on GMP requirements at regular intervals.

QA Technical Specialist – Contract

Pfizer (PGS)
Mulgrave, VIC
03.2022 - 09.2022
  • Conducted investigations and approved deviation events and CAPA initiatives.
  • Facilitated transition from Trackwise Event System to Vault (eQMS) System.
  • Ensured compliance through thorough evaluation of corrective actions and preventive measures.

QA Associate - Vendor Assurance fixed 12 month contract

Aspen Australia
Dandenong South, VIC
05.2021 - 03.2022
  • Acquired Sigma Pharmaceutical, integrating products into Aspen Australia's portfolio successfully.
  • Mapped supply chain to align with updated PICS GMP guidelines for medicinal products.
  • Ensured compliance with TGA requirements through strategic vendor management.
  • Achieved process implementation within six months from project initiation.

National QA & Compliance Manager

Jasol Australia P/L
Braeside, VIC
09.2017 - 12.2020
  • Ensured maintenance of ISO9001:2008 and ISO14001:2008 accreditations.
  • Coordinated compliance with regulatory requirements from Work Safe Australia and ISO Standards Australia.
  • Promoted a safe working environment through rigorous health and safety protocols.
  • Focused on continuous improvement across all areas of responsibility.
  • Led internal audits to ensure adherence to compliance standards.
  • Maintained integrated management systems and established procedures.
  • Facilitated development and training for new business procedures.
  • Managed compliance registration and licensing across multiple states.

Quality Assurance Manager

Dentalife Australia Pty Ltd
Ringwood, VIC
10.2016 - 09.2017
  • Elevated Quality Accreditation Level from ISO 13485 Class I to Class IIB and III.
  • Corresponded with TGA to manage Manufacturing Site registration compliance.
  • Merged QMS for Australia and Thailand into a unified Quality Management system.
  • Conducted Internal Audits on-site and at sister company in Thailand.
  • Established manufacturing capabilities for Medical Device Class IIB and III registered products.
  • Administered training programs for personnel to meet established competencies.
  • Managed small company laboratory for initial approval of chemical solutions in new product batches.

Quality Assurance Manager and Site Quality Representative

The Gourmet Nut Company Pty Ltd
Mordialloc, VIC
08.2013 - 09.2016
  • Developed and managed FMCG food safety accredited quality system.
  • Ensured timely communication of regulatory updates across all site operations.
  • Represented company in all food safety communications with key clients, including Woolworths and Coles.
  • Trained personnel on food safety requirements to maintain compliance standards.
  • Approved all new and redesigned products to meet safety criteria.
  • Maintained chemical and microbiological testing regimes for product assurance.
  • Coordinated OHS steering committee, providing training and mentoring on safety protocols.
  • Liaised with management regarding occupational health and safety issues.

Validation Specialist /Consultant

Pharmout P/L
Glen Waverley, VIC
02.2012 - 07.2013
  • Designed and executed validation protocols for new and existing equipment in pharmaceutical companies, including CSL Broadmeadows and Parkville.
  • Delivered expertise in validation and quality systems for pharmaceutical industry projects.

Quality, OH & S, Training, and Compliance Manager

DeltaPak Pty Ltd.
Bayswater North, VIC
02.2008 - 02.2012
  • Executed contract manufacturing of Baby Skin Wipes, cleaning wipes, and disinfectant solutions for homewares.
  • Implemented systems compliant with GMP to achieve ISO13485 certification.
  • Designed and delivered GMP training program for all personnel.
  • Managed daily responsibilities of Quality Control Auditor.
  • Oversaw web-based document system to maintain compliance.
  • Ensured documented procedures remained effective and relevant.
  • Chaired OHS Steering Committee, facilitating OHS Representatives and providing employer support.

QA/QC & Training Manager

Delta-pak Pty. Ltd. / Atherton Chemicals
Bayswater North, VIC
02.2008 - 12.2010
  • Elevated Quality Accreditation from ISO 9001 to ISO 13485.
  • Conducted internal audits on-site and for sister company, ensuring compliance.
  • Established manufacturing capabilities for Medical Device registered products.
  • Administered training programs to meet competencies for ISO 9001 and 13485.
  • Oversaw laboratory operations for first-off approval of chemical solutions in new product batches.
  • Managed contract manufacturing of Baby Skin Wipes, cleaning wipes, and disinfectant solutions.
  • Produced plumbing glues and sealing products under Atherton Chemicals brand.

Validation Specialist /Consultant

Pharmout P/L
Glen Waverley, VIC
05.2007 - 02.2008
  • Designed and executed validation processes for new and existing equipment in pharmaceutical industry.
  • Delivered quality system expertise to CSL Parkville for enhanced operational compliance.
  • Conducted thorough assessments to ensure adherence to industry standards and regulations.
  • Collaborated with cross-functional teams to streamline validation protocols.
  • Implemented robust documentation practices to maintain quality assurance during validations.

Internal Audit Co-ordinator

Sigma Pharmaceuticals
Dandenong South, VIC
05.2006 - 04.2007
  • Conducted internal audits across three facilities to enhance compliance and operational efficiency.
  • Managed audit processes, ensuring thorough evaluation of pharmaceutical manufacturing practices.
  • Designed comprehensive audit frameworks to identify risks and implement corrective actions.

Validation Specialist /Consultant

Synertec Lifesciences
Melbourne, VIC
06.2004 - 05.2006
  • Delivered validation and quality system expertise in pharmaceutical industry.
  • Designed and executed validation protocols for new and existing equipment at Mayne Pharma Mulgrave.
  • Ensured compliance with regulatory standards through thorough validation assessments.
  • Collaborated with cross-functional teams to optimize quality systems and processes.

Validation Specialist / Continuous Improvement Co-ordinator

Smith & Nephew P/L, Hull, UK
Hull, UK
06.1999 - 09.2003
  • Executed validation training for all engineering and process technicians company-wide.
  • Advised on compliance-driven validation processes across diverse projects.
  • Reviewed and approved DQ, IQ, OQ, and PQ documents to ensure quality standards.
  • Facilitated continuous improvement teams on-site, promoting operational excellence.

Quality Manager

Hosico Engineering
Braeside, VIC
01.1996 - 12.1999
  • Specialized in injection moulding for plastics and CMC metal components.
  • Delivered high-quality products through advanced manufacturing techniques.
  • Ensured compliance with industry standards and regulations.
  • Collaborated with design teams to optimize product specifications.

Quality Manager

IFC (Industrial Flock Coatings)
Carrum Downs, VIC
01.1992 - 12.1996
  • Executed flock coating processes for plastic mouldings in automotive sector.
  • Enhanced product durability and aesthetics through advanced coating techniques.
  • Ensured compliance with industry standards and regulations during production.
  • Streamlined production workflows to increase efficiency and reduce waste.
  • Collaborated with design teams to develop customized coating solutions.
  • Trained staff on best practices for flock coating applications and safety protocols.
  • Conducted quality inspections to guarantee high standards of finished products.

Quality Supervisor (then Manager)

Bridgestone Australia
Dandenong, VIC
01.1988 - 12.1992
  • Provided innovative foam solutions for automotive seating applications.
  • Delivered high-quality products, meeting industry standards and customer specifications.
  • Collaborated with cross-functional teams to enhance product design and functionality.
  • Implemented quality control measures to ensure consistency in production processes.

Education

Principles and Applications of HACCP -

SAI Global
Melbourne, VIC
12.2024

Fire Warden - Fire Warden

Workplace Emergency Management
Notting Hill, VIC
12.2023

Food Safety Supervisor - Food Safety

SAI Global
Melbourne
12.2013

Principles and Applications of HACCP - HACCP Food Safety

SAI Global
Melbourne, VIC
12.2013

Allergen Management for Food Manufacturers & Allergen Labelling VITAL 2 - VITAL - Allergen

SAI Global
Melbourne Airport, VIC
12.2013

OH & S Manager, Rep Training - Occupational Health And Safety

Ergosh P/L
Melbourne, VIC
12.2011

Lead Auditor - Lloyds - Lead Auditor

Bywater UK
Oxford UK
12.2000

Certificate Quality Technology - Quality Technology

Swinburne College
Swinburne Vic
12.1992

Skills

  • ISPE
  • ISO 9001:2001
  • OH & S
  • Food Safety Supervisor
  • HACCP
  • Allergen Management
  • Allergen Labelling
  • Fire Warden
  • TGA
  • GMP
  • Australian Certified Organics
  • Kosher
  • PIC/S
  • FSANZ
  • CAPA
  • PICS-GMP
  • ISO9001:2015
  • ISO14001
  • Work Safe Australia
  • ISO 13485
  • FMCG
  • OHS
  • Food Safety Manufacturing Edition 9

Hobbies and Interests

  • Showing and Breeding of Newfoundland Dogs
  • Promotion of the working attributes of the breed

References

  • Subrata Biswas, Managing Director, GSM Group, 0401682532, Subrata.biswas@foodpac.com.au
  • Zaherra Hoosman Giannakoulia, Head of Group Quality, Ixom, 0483169430, zaherra.hoosman.giannakoulia@ixom.com.au
  • Slobodanka (Boba) Simic Avramovic, Quality Control Manager, ABP, Slobodanka.simic.avramovic@ixom.com.au

Affiliations

  • Breeding and Showing Newfoundland Dogs
  • Qualified Dog training Instructor

Timeline

Quality Assurance Manager

QSM Group (t/a Food-Pak)
05.2025 - Current

Quality Assurance Manager

IXOM (ABP – Hallam)
11.2022 - 05.2025

QA Technical Specialist – Contract

Pfizer (PGS)
03.2022 - 09.2022

QA Associate - Vendor Assurance fixed 12 month contract

Aspen Australia
05.2021 - 03.2022

National QA & Compliance Manager

Jasol Australia P/L
09.2017 - 12.2020

Quality Assurance Manager

Dentalife Australia Pty Ltd
10.2016 - 09.2017

Quality Assurance Manager and Site Quality Representative

The Gourmet Nut Company Pty Ltd
08.2013 - 09.2016

Validation Specialist /Consultant

Pharmout P/L
02.2012 - 07.2013

Quality, OH & S, Training, and Compliance Manager

DeltaPak Pty Ltd.
02.2008 - 02.2012

QA/QC & Training Manager

Delta-pak Pty. Ltd. / Atherton Chemicals
02.2008 - 12.2010

Validation Specialist /Consultant

Pharmout P/L
05.2007 - 02.2008

Internal Audit Co-ordinator

Sigma Pharmaceuticals
05.2006 - 04.2007

Validation Specialist /Consultant

Synertec Lifesciences
06.2004 - 05.2006

Validation Specialist / Continuous Improvement Co-ordinator

Smith & Nephew P/L, Hull, UK
06.1999 - 09.2003

Quality Manager

Hosico Engineering
01.1996 - 12.1999

Quality Manager

IFC (Industrial Flock Coatings)
01.1992 - 12.1996

Quality Supervisor (then Manager)

Bridgestone Australia
01.1988 - 12.1992

Principles and Applications of HACCP -

SAI Global

Fire Warden - Fire Warden

Workplace Emergency Management

Food Safety Supervisor - Food Safety

SAI Global

Principles and Applications of HACCP - HACCP Food Safety

SAI Global

Allergen Management for Food Manufacturers & Allergen Labelling VITAL 2 - VITAL - Allergen

SAI Global

OH & S Manager, Rep Training - Occupational Health And Safety

Ergosh P/L

Lead Auditor - Lloyds - Lead Auditor

Bywater UK

Certificate Quality Technology - Quality Technology

Swinburne College

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