Quality Assurance Manager – TGA Licensed Manufacturer (The position has been filled)
Australia, Victoria
Full Time
07/06/2017
  • Leading Australian Owned Organisation with research, manufacturing and operational facilities
  • Complete contract manufacturing solutions in skin care and cosmetics
  • Senior role with excellent salary and working conditions

 

COMPANY

Based in Melbourne, our client is a full service TGA licenced manufacturer of topical products and cosmetics. They offer a full, end-to-end service, transforming client concepts into commercially successful products. Their core expertise includes sun care, personal care, skin care, cosmetics and topical therapeutic products. Their state of the art purpose built facility, provides customers with a complete contract manufacturing solution including R&D, Product Development, Regulatory Support, Quality Assurance, Quality Control, Warehousing as well as local and international distribution.

 

ROLE

Reporting to the Managing Director and with two direct reports, this role is responsible for the implementation and maintenance of the company’s Quality Assurance system in compliance with local and/or overseas regulatory requirements and the company’s objectives.

Main responsibilities include:

  • Ensure the company’s internal and external processes and suppliers are regularly reviewed as part of the company’s continues improvement program
  • Maintain and review systems that are in place to ensure that products produced by the company meet customer specifications and relevant regulatory requirements including TGA licensing for the manufature of sunscreens
  • Ensure all testing conducted by the QC laboratory is completed in an efficient, accurate and timely manner
  • Oversee the testing, release or, rejection of raw materials, packaging, intermediate product, bulk product and finished products
  • Provide training in the requirements of the Australian Code of Good Manufacturing Practice (cGMP) for Medicinal Products
  • Provide guidance in the area of regulatory affairs
  • Preparation of submissions for relevant regulatory bodies

 

SELECTION CRITERIA

The successful candidate will be an experienced Quality Manager of a TGA licensed facility. You will have leadership qualities, be customer focused, a decision maker and able to complete tasks and projects on time.

To be successful in your application, you will need to meet the following criteria:

  • Science degree in chemistry, biology or a related discipline
  • Excellent working knowledge of the Australian Therapeutic Goods (TGA) Act and its requirements
  • Experience and knowledge of the Australian cGMP for Medicinal Products
  • Minimum 10 years’ experience in Pharmaceuticals or Complementary Medicines mainly in the areas of Manufacturing, QA/QC and Regulatory Affairs
  • Understanding of GMP requirements, processes and quality aspects of company operations
  • Understanding of regulatory requirements for therapeutic and non-therapeutic products, including a working knowledge of Quality Risk Management and Compliance
  • Excellent interpersonal, leadership, time management and organisational skills
  • High attention to detail
  • Troubleshooting and investigation skills
  • Hazard and·risk identification/assessment
  • Excellent verbal and written communication skills
  • Positive and proactive attitude
  • Ability to prioritise and multi-task
  • Excellent administrative skills
  • The ability to nurture relationships internally and externally

 

APPLICATIONS

To apply for this role, please click the ‘Apply Now’ button below and send your updated resume with a covering letter to CS Executive Group. For a confidential discussion about this role, please call Helen or Jo on 03 9516 0100 during office hours. After hours, please call Helen on 0438 620 434.

 

THANK YOU

We would like to thank you for taking the time to apply for this role. Unfortunately, due to the large volume of candidates we receive on a daily basis, we can only contact those with suitable qualifications and experience. If on this occasion you are not successful, your resume will remain on our database and be considered for future suitable roles.