26/03/2021
๐ช๐ข๐ฅ๐ ๐ช๐๐ง๐ ๐จ๐ฆ โข Quality Assurance Specialist
๐๐๐ก๐ก๐๐ฃ๐๐๐๐๐๐ is an Australian biopharmaceutical startup in its second year of operations, focused on the cannabinoid pharmaceutical sector. Our diverse team of pharmaceutical experts, doctors, researchers and horticulturists are focused on providing patients access to unique delivery systems and formulations that are symptom specific.
We are entering a high growth phase and are building out our Quality Assurance function in our Northern Rivers facility for its first growth cycle. As such, we require a Quality Assurance Specialist to support the implementation and management of the CannaPacific Quality Assurance & Control System to ensure compliance with TGA cGMP requirements for the manufacture of medicinal products. This role reports directly to the Chief Scientific Officer with development and progression opportunities as the department grows.
๐๐๐ฌ ๐ฅ๐๐ฆ๐ฃ๐ข๐ก๐ฆ๐๐๐๐๐๐ง๐ฌ ๐๐ฅ๐๐๐ฆ
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Implementation and maintenance of validated quality processes including establishing product specifications and quality attributes; measuring product quality; establishing documentary evidence; determining operational and performance qualification; writing and updating quality assurance procedures compliant with the TGA cGMP requirements.
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Prepare quality systems documentation and reports by collecting, analysing and summarising information and trends including process deviations, stability studies, recalls, corrective and preventative actions (CAPA), and process and analytical validation.
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Responsible for obtaining and collating trends in product quality critical parameters including annual product quality reviews.
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Accountable delegate for product release of all products for sale after review of all associated manufacturing documentation for compliance to cGMP.
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Develop quality assurance plans by conducting risk analyses; identifying critical control points and preventive measures; establishing critical limits, and monitoring procedures.
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Maintain and improve overall compliance including investigation of all customer complaints and process deviations.
Responsible for overseeing the outsourcing of requisite analytical methods in accordance with the cGMP procedures and product release specifications.
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Train and develop staff reporting to this position to assist them to maximise their job satisfaction and contribution to overall company objectives.
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To train and develop wherever possible a competent replacement or stand-in staff member for this position.
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Training and development of team members and cross-functional departments.
๐๐ฒ๐ ๐พ๐๐ฎ๐น๐ถ๐๐ถ๐ฒ๐:
Committed to maintaining a High Level of compliance
Enthusiastic, and committed to continuous improvement
Strong drive to meet agreed goals
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๐ฝ๐ฒ๐ฟ๐ถ๐ฒ๐ป๐ฐ๐ฒ ๐ฟ๐ฒ๐พ๐๐ถ๐ฟ๐ฒ๐ฑ:
โ Pharmaceutical experience in a quality department role in the pharmaceutical manufacturing environment or equivalent
โ A degree qualification in scientific discipline
โ Experience and strong understanding of Australian TGA cGMP manufacturing requirements for medicinal products or active pharmaceutical ingredients
โ Experience with HPLC and/or GC analysis methodologies is also desired
๐ง๐ต๐ฒ ๐๐๐ฐ๐ฐ๐ฒ๐๐๐ณ๐๐น ๐ฎ๐ฝ๐ฝ๐น๐ถ๐ฐ๐ฎ๐ป๐ will be required to undergo a national police check and supply details of two work-related referees. Please note that you must be willing to undergo regular and ad hoc drug testing as a requirement of the regulations within the industry.
The is a full-time position based in the beautiful Northern Rivers region - commutable from Byron Bay, Lenox Head and Ballina. Relocation assistance will be offered. You will also be offered on-site parking, ongoing training and support, autonomy and the opportunity to work in a friendly, supportive team-based environment.
If you have the necessary qualifications and experience and are interested in applying for the role, we canโt wait to hear from you - please apply today. We note only successful applicants will be notified.
๐ฑ ๐ง๐ข ๐๐ฃ๐ฃ๐๐ฌ: please send your resume to narelle@cannapacific.com.au
***๐ง๐ต๐ถ๐ ๐ฝ๐ผ๐๐ถ๐๐ถ๐ผ๐ป ๐ถ๐ ๐ป๐ผ๐ ๐ผ๐ฝ๐ฒ๐ป ๐๐ผ ๐ฟ๐ฒ๐ฐ๐ฟ๐๐ถ๐๐บ๐ฒ๐ป๐ ๐ฎ๐ด๐ฒ๐ป๐ฐ๐ถ๐ฒ๐.
