Maintain Quality Assurance System to ensure compliance with company and cGMP standards
Responsible for maintaining audit program, reviewing functional and release documentation and investigating deviations relevant to area of responsibility
Reviews lot release documentation and facilitates compliant release process for corresponding market
Responds to questions from authorities (TGA, FDA, etc.) to ensure timely product release
Ensures standard operating procedures (SOP’s) stay current and align with corporate and regulatory requirements
Executes training/awareness related to GMP standards
Skills/experience:
Tertiary education in a scientific discipline
Previous quality/manufacturing experience in a similar role in the biotechnology or pharmaceutical industry
Knowledge of current Good Manufacturing Practices (cGMP) principles
Knowledge of TGA, FDA and EMA requirements
Batch release experience
Excellent written and oral communication skills
Excellent problem-solving skills and time management
Apply! If you think this could be the role for you then please apply now! Please send us a cover letterAND a detailed resume in WORD format (PDFs can be corrupted / not processed). Or, if you have any questions, please contact Priyanka on 03 9040 1630.
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
Submission Form
Submit your message along with your CV attached, and one of our specialists will be in touch.