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Quality Control Document Specialist
2 weeks ago
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, formulation, 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, ISO 22716:2007, ISO9001:2015 regulations. 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 Control (QC) Document Specialist plays a crucial role in ensuring the quality of products, services, or processes within UA Manufacturing. This role will ensure Quality Control documents are compliant with current Good Manufacturing Practice (cGMP), Site Standard Operating Procedures, and safety practices.
KEY RESULT AREAS AND ASSOCIATED TASKS/ACTIVITIES
- Create chemical raw materials specifications to align with applicable USP, BP Pharmacopoeias, and other regulatory guidelines.
- Establish and update specifications and standards for control of packaging and finished products.
- Create, format, update, and review QC documents (SOPs, work instructions, QC test method and record sheet, forms, logbooks) to ensure compliance with GMP regulations.
- Prepare method validation protocols and reports. Ensure documents are technically accurate and consistent with internal style guidelines for format, clarity, and flow
- Update QC documents for continuous improvement relating to deviations, lab errors, and audit findings
Drive the vendor qualification process to support QA, including:
Sending out questionnaires to the vendors and following up on responses.
- Collecting vendor documentation, including their quality management system (QMS), compliance history, and relevant certifications.
- Adding the approved qualified vendors to an Approved Supplier List (ASL).
- Support the monitoring of vendor performance, including quality, delivery, and compliance.
OTHER REQUIREMENTS
- Minimum degree qualification in Chemistry or a Science-related discipline.
- Strong scientific knowledge in Chemistry tests.
- Previous Pharmaceutical (GMP) or related industry experience (minimum 2 years).
- Understanding of the USP, BP & EP pharmacopoeias.
- Strong knowledge of QC/QA procedures required to maintain compliance.
- Strong organizational and administrative skills: Essential for managing and tracking large volumes of documentation.
- Proficiency in Microsoft Office Suite: Including Word and Excel, for document creation, editing, and analysis.
- Knowledge of quality control processes and procedures: Understanding the principles of quality control and how they relate to documentation.
- Attention to detail: Ensuring accuracy and completeness of all documentation.
- Excellent communication and interpersonal skills: To effectively collaborate with various teams and stakeholders.
- Familiarity with relevant industry standards and regulations: ISO standards, TGA regulations, etc.
- Accuracy, clarity, and adherence to Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) are crucial for this role.
If this is the next challenge you are looking for, please apply now in SEEK. Please note only shortlisted candidates will be contacted.
