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.

Established in 1997 as a single site operation, Probiotec Limited has a reputation for innovation and rapid response to market opportunities. Its growth has been fuelled by strong organic growth and strategic acquisitions along with relationships and joint ventures with global market participants that want to conduct business with a company that maintains high levels of quality and innovation.

Since beginning operations in 1997, Probiotec has quickly emerged as a leading manufacturer, marketer and distributor of a diverse, high quality range of prescription and over-the-counter (OTC) pharmaceuticals, complementary medicines and specialty ingredients.

Listed on the Australian Stock Exchange (ASX) since November 2006, our Australian owned and operated company has built an enviable reputation for developing innovative new pharmaceutical, nutraceutical and cosmeceutical products which not only address researched consumer needs, but also succeed in gaining the clinical approvals necessary to respond rapidly to market opportunities, both domestically and internationally.





What separates Probiotec from other trusted contract manufacturers is not only that we invest so heavily in Research and Development; equip our production facilities with the latest new technologies; employ chemists and microbiologists of the highest calibre and maintain Quality Assurance standards that are second to none, but we also manufacture and market our own products. As a result, we have a full understanding of the process and dynamics of developing formulations (and brands) for the retail market that deliver margins that optimise return-on-investment.

Our proven experience and expertise extends across a wide range of healthcare goods – offering you access to a cost-efficient contract manufacturer of existing Probiotec formulations, new custom developed formulations or formulations which you already possess and wish to produce in a wide range of categories.

Source: this is an extract from the company’s own website

Established in 1997 as a single site operation, Probiotec Limited has a reputation for innovation and rapid response to market opportunities. Its growth has been fuelled by strong organic growth and strategic acquisitions along with relationships and joint ventures with global market participants that want to conduct business with a company that maintains high levels of quality and innovation.

Since beginning operations in 1997, Probiotec has quickly emerged as a leading manufacturer, marketer and distributor of a diverse, high quality range of prescription and over-the-counter (OTC) pharmaceuticals, complementary medicines and specialty ingredients.

Listed on the Australian Stock Exchange (ASX) since November 2006, our Australian owned and operated company has built an enviable reputation for developing creative new pharmaceutical, nutraceutical and cosmeceutical products which not only address researched consumer needs, but also succeed in gaining the clinical approvals necessary to respond rapidly to market opportunities, both domestically and internationally.

What separates Probiotec from other trusted contract manufacturers is not only that we invest so heavily in Research and Development; equip our production facilities with the latest new technologies; employ chemists and microbiologists of the highest calibre and maintain Quality Assurance standards that are second to none, but we also manufacture and market our own products. As a result, we have a full understanding of the process and dynamics of developing formulations (and brands) for the retail market that deliver margins that optimise return-on-investment.

Our proven experience and expertise extends across a wide range of healthcare goods – offering you access to a cost-efficient contract manufacturer of existing Probiotec formulations, new custom developed formulations or formulations which you already possess and wish to produce in a wide range of categories.

Source: this is an extract from the company’s own website

#J-18808-Ljbffr

📌 Quality Assurance Associate - Complaints (Melbourne)
🏢 Probiotec Pharma
📍 Melbourne