ABOUT THE COMPANY
UA Manufacturing is a new subsidiary located in Altona North Melbourne, invested by Uniasia Cosmetics Technology, a world-famous international cosmetics manufacturer.
Specializing in the procurement, development, manufacturing, filling and packing of beauty and cosmetics products, we are passionate about cosmetics and beauty, and committed to offering superior and value-added services, such as product development, custom formulation and manufacturing solutions.
Our state-of-the-art facility has been built in strict accordance with TGA, GMP, ISO9001:2015, ISO 22716:2007 regulations and to meet the standard of a 100,000-purification factory. This ensures we have a superior clean production environment in our facility. In addition, we have sourced the world's leading automated production equipment which greatly enhances our production efficiency, saving on our client's time and costs.
As one of the largest cosmetic OEM in Australia we have a rapidly expanding customer base. At UA Manufacturing you can grow and develop as we do.
SUMMARY OF ROLE
The Quality Assurance Manager will oversee the activity of the quality management system, developing, implementing, and maintaining a system of quality and reliability testing for the organizations products and/or development processes.
KEY RESULT AREAS AND ASSOCIATED TASKS/ACTIVITIES
1.Quality system development and maintenance
- Develop, implement, and maintain the Quality Management System.
- Design and implement quality training programs to key personnel in conjunction with relevant managers, implement training programs in production and quality management in collaboration with HR department.
2.Certification projects and external audits
- Leading the major factory qualification program, TGA licensed manufacturer, ensuring smooth official audits, as well as system operation and maintenance after certification.
- Be Audit ready at all times; as the company's representative to receive all kinds of system certification audit, including but not limited to ISO9001, GMP(ISO22716), COSMOS, SMETA, etc.
- Manage internal and external support program audits (such as 2nd party audit from clients) including the corrective action request process and system.
3.Internal quality management- internal audit and management review
- Support production targets whilst maintaining plant and product standards and specifications. Report to management on performance of the QMS, highlighting areas for improvement.
- Formulate and maintain quality objectives complementary to corporate policies and goals.
- Gather and analyse audit data and make recommendations regarding quality outcomes and compliance with Quality Assurance requirements.
4.Approved supplier program, customer satisfaction and complaints
- Establish and implement approved supplier management programs, collect and organize supplier information, and organize document or on-site audits of suppliers when necessary
- Investigate customer complaints regarding quality. Complete customer complaint reports and consistently drive customer satisfaction.
5.Deviation follow-up, corrective action and continuous improvement
- Work closely with QC department to ensure that quality issues occurring during material inspection and production are effectively addressed.
- Facilitate deviation follow-up activities and organize resources from all parties to follow up and close problems that have been identified.
6.Document and record management
- Collection and daily management of various technical documents to ensure their availability and validity; establishment of raw material database; review, approval and maintenance of specification database for actual production practice.
- Examine and file all kinds of production records.
7.Compliance project and technical service for internal & external brands -assisting BD
- Evaluate and/or prepare documentation based on current regulations and/or requirements.
- Ensure ongoing compliance with quality and industry regulatory requirements.
- Communicate with the BD, R&D team and assist as needed; Cooperate with external customers to complete various requests, such as collecting and organizing documents, cooperating with the completion of product certification projects, etc.
- Responsible for various compliance programs for the internal brand and external brands, such as official registration in other countries, various certificates, etc.
OTHER REQUIREMENTS
1.Experience/Knowledge Required (state depth)
- Bachelor's degree in a relevant scientific, pharmaceutical, or engineering field.
- A minimum of two years of progressive experience in Quality Assurance management roles within the pharmaceutical, biotechnology, or related industry, with a strong emphasis on compliance with regulatory standards.
- Demonstrated experience in implementing, managing, and enhancing Quality Management Systems (QMS) in accordance with TGA guidelines and Good Manufacturing Practice (GMP) standards.
- In-depth understanding of TGA regulatory requirements, guidelines, and legislation relevant to the manufacturing and control of therapeutic goods.
- Familiarity with international quality and regulatory standards (e.g., GMP, ISO) that complement TGA requirements, enhancing the organization's compliance and Quality Assurance capabilities.
- Ability to interpret and apply regulatory guidelines to operational processes and quality management practices, ensuring consistent compliance.
2.Technical Capability
- Excel - Intermediate
- Outlook- Intermediate
- MSWord - Intermediate
- Qualifications/Certifications Required-Not required
3.Behavioral Competencies
- Project Management
- Teamwork
- Attention to detail
- Proactive
- Problem Solving
- Communication
- Intellectual Curiosity
Please apply in SEEK now if this is the next challenge you are after.