About Probiotec:

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, offering a 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.
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