facebook

Job details

Location
Sydney
Salary
Negotiable
Job Type
Full Time
Ref
38494
Contact
Madeleine Byrnes
Posted
16 days ago

Job details

Location
Sydney
Salary
Negotiable
Job Type
Full Time
Ref
38494
Contact
Madeleine Byrnes
Posted
16 days ago

About the company

A distinguished global pharmaceutical company with facilities worldwide. The company prides itself on compounding products of the highest quality by having a proactive approach to enhancing quality control. The company believes their best asset is their people and they are passionate about working collaboratively to make a difference to the lives of millions of people.

About the opportunity

As the Quality Manager, you will be supervising a team and overseeing the operations of all Quality related matters. You will be utilising your expertise to maintain an 'audit-ready' environment and implement strategies with a focus on continuous improvement.

Duties

  • Review and implement strategies to enhance process performance and product quality
  • Ensure the escalation and response to quality issues
  • Authorise the release for supply
  • Ensure the compliance with cGMPs and relevant regulatory guidelines
  • Review and approve all Quality related documentation
  • Maintain and enhance Quality Management systems to release or reject products, packaging, and labelling materials
  • Oversee the management of CAPAs, deviations, complaints, and validation activities
  • Be the primary point of contact for regulatory inspections and the response to observations and corrective actions required

Skills and Experience

  • Bachelor's degree in a scientific related discipline
  • Management experience in Quality Assurance and/or Regulatory Affairs within a TGA regulated and cGMP environment
  • Ability to prioritise and problem solve
  • Excellent communication skills
  • Ability to maintain positive working environment and coach a team
  • Proficiency in Microsoft applications

How to Apply

Click apply or contact Madeleine Byrnes, Sourcing Consultant on 0288778703 for a confidential discussion.

Similar jobs

16 days ago

Quality Assurance

Quality Manager

  • New South Wales
  • Negotiable

About the companyA distinguished Australian medical device company that manufactures and distributes a vast range of medical and surgical products. They strive to offer innovative solutions to make a difference to patients lives. The company have a collaborative culture and pride themselves on their environmentally sustainable practices. About th...

4 days ago

Executive Roles

Head of Quality - Medical Devices

  • New South Wales
  • Attractive Remuneration Package

Benefits Opportunity to lead a team as the Head of Quality operations at Cyclomedica, an Australian owned and rapidly growing medical device company. You will be exposed to a wide range of local and overseas regulations as the product is marketed in 60 countries worldwide and is on the cusp of entering the US market with their ground-breaking medical innovations...

9 days ago

Quality Assurance

Senior Quality Assurance Associate

  • Kingsgrove
  • Negotiable

BenefitsThe opportunity to be a Senior Quality Assurance Associate at Cyclopharm has become available. You will have the unique opportunity to gain experience within Quality Assurance at a company on the cusp of joining overseas markets with their ground-breaking medical innovations.About the companyWith over 30 years' exp...

30 days ago

Quality Assurance

Quality Control Associate

  • Northern Beaches
  • AU$70000 - AU$80000 per annum + super + salary packaging

About the company Small scale packaging facility of vitamins and minerals. The company is part of a larger not-for-profit organisation passionate about improving lives by creating career opportunities for people with disabilities. About the opportunity This is a 12-month contract role (with possible extension) for a Qua...

24 days ago

Quality Assurance

APS 6 Compliance Assessor

  • Canberra
  • Negotiable

BenefitsGain unique experience in technical and regulatory affairs working for the Medical Devices Authorisation Branch of the TGA. About the companyThe Medical Devices Authorisation Branch of the TGA evaluates medical devices, including in vitro diagnostic medical devices (IVDs), and monitors them throughout their lifecycle to en...

3 days ago

Quality Assurance

Regulatory Affairs Manager

  • New South Wales
  • Negotiable

About the companyA distinguished global pharmaceutical company specialising in generic medicines with facilities worldwide. The company prides itself on their strong R&D focus that has resulted in an exciting product pipeline. The company also has expertise in all aspects of the drug development process from product formulation to the manufacturing of the product....

21 days ago

Regulatory Affairs

Regulatory Affairs Associate

  • New South Wales
  • Negotiable

About the companyA distinguished Australian medical device company that manufactures and distributes a vast range of medical devices and surgical products. The company strives to offer innovative solutions to make a difference to patients lives. They have a collaborative culture and pride themselves on their environmentally sustainable practices.