Quality Assurance Associate - Complaints

Probiotec; City of Melbourne; On-site; AUD 65,000 - 105,000; Full time

Job summary

Probiotec is seeking a Quality Assurance Associate focused on complaints to strengthen our GMP-compliant QA systems across its Australian sites. You will investigate complaints, coordinate with departments to implement corrective actions, and support audits and the maintenance of QA documentation.

Ideal candidates hold a science degree with experience in QA, GMP/GLP knowledge, and strong communication skills.

Qualifications

• Bachelor's degree in Science or related field is preferred.
• Experience implementing corrective action programs and QA methodologies.
• Professional scientific competency in QA principles.
• Understanding of GMP, GLP and regulatory affairs.
• Strong organizational and time management skills.
• Excellent communication and report writing abilities.
• Ability to apply QA frameworks and systems in pharmaceutical environments.
• Teamwork and cross-functional collaboration across levels.
• Ability to work both in a team and autonomously.
• Willingness to learn new QA methods and manage multiple tasks.

Responsibilities

• Manage, investigate, and respond to customer complaints and inquiries with timely documentation and root-cause analysis.
• Assist Quality Manager with maintenance of QA systems to ensure GMP compliance.
• Coordinate mock recalls and assess recall effectiveness.
• Audit manufacturing/packaging batch records for GMP compliance and release for supply.
• Ensure batches follow SOPs and batch record requirements.
• Prepare/Review SOPs as needed.
• Perform deviation investigations and document issues.
• Prepare change controls, temporary variations, and risk assessments.
• Monitor corrective actions and assess effectiveness.
• Assist with cleaning validation data collection and reporting.
• Approve GMP documentation including specs, sampling, test methods, SOPs, deviations, and change controls.
• Manage Deviations, CAPAs and Change Requests.
• Prepare reports and data for Product Quality Reviews.
• Assist in vendor assurance program management.
• Prepare monthly reports for Quality Manager.
• Conduct internal audits to ensure GMP compliance.
• Other duties as assigned by the Department Manager.

Skills

Strong organizational & time mgmt

Communication & report writing

Teamwork

Autonomy

Learn new methods

Education

Bachelor's degree in Science or related field

Job description

Quality Assurance Associate - Complaints

Probiotec is a leading provider of contract manufacturing and packing services in the pharmaceutical and associated sectors, providing best-in-class solutions to a diverse range of clients.Since beginning operations in 1997, Probiotec has quickly emerged as a leading manufacturer and packer of a diverse, high-quality range of prescription (‘Rx’) and over-the-counter (‘OTC’) pharmaceuticals, complementary medicines and consumer health products.

The business is also one of Australia’s largest packing companies, offeringa multitude of packing services – including primary, secondary & co-packing capabilities as an end-to-end manufacturing and packing partner. With 3 sites across Australia including Probiotec Pharma, LJM and Probiotec Multipack, the group is responsible for employing over 1000 employees nationwide. As a leader in Australian manufacturing and packing services, Probiotec provides innovative healthcare products that improve the lives and well-being of our customers.

Main Objectives:

Ensure that Probiotec Quality Assurance functions are done in accordance with the requirement of Australian Code of GMP for Medicinal Products.

Assist Quality Manager in maintenance of QA systems in accordance with Code of GMP to ensure a smooth audit trail is achieved

Primary Responsibilities:

Manage, investigate, and respond to Customer complaints and Customer enquiries in a timely and appropriate manner by acknowledging and documenting complaints, conducting thorough investigations to determine root cause, and coordinating with relevant departments to implement corrective actions.

Assist the Quality Manager in maintenance of Quality systems

Coordinate mock recall activity and evaluate effectiveness of recall procedure.

Perform audits of manufacturing and packaging batch records for GMP compliance and Release for Supply

Ensure batches are manufactured/packed according to the SOP and batch record requirements.

Preparation/Review of standard operating procedures where necessary.

Perform deviation investigation and document any issues that arise from the deviation.

Prepare change control, temporary variations, and risk assessment as and when required.

Monitor implementation of corrective actions and evaluate its effectiveness.

Assist with cleaning validation data collection and reporting where required.

Delegate for approval of GMP documentation (including product specifications, sampling instructions, test methods, SOPs, deviations and change control and other Quality Control and Quality Assurance procedures).

Delegate for management of Deviations, CAPAs and Change Requests

Preparation of reports and collation of data for Product Quality Reviews as required.

Assist in managing vendor assurance program, as and when necessary.

Prepare monthly reports for the Quality Manager.

Perform internal audits of processes and systems to ensure compliance with GMP regulations.

Other duties may be assigned from time to time as deemed appropriate by the Department Manager.

Prerequisites:

Bachelor’s degree in Science or other related field highly regarded.

Experience with implementation of corrective action programs, knowledge of tools, concepts, and methodologies of QA.

Professional scientific competency.

Understanding of GMP, GLP and regulatory affairs.

Strong organizational and time management skills

Communication and report writing abilities.

Ability to apply and implement frameworks and systems appropriately in the pharmaceutical environment.

Team working skills to work cooperatively and liaise with people at all levels.

Capacity to work in a team as well as autonomously when required.

Ability to learn new methods and techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.