Come join a company that tackles fascinating problems and finds solutions to complex challenges.Seqirushas an exciting opportunity to join our expanding team in Parkville, a leader in egg-based influenza vaccine manufacturing, in-licensed vaccines and specialty pharmaceuticals.Seqirusis the sole supplier of a unique range of products made in the national interest for the Australian Government. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats. When you joinSeqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.
Located in Parkville (Australia) and part of the Quality Assurance Department, this role is afull-timefixed term contract. Reporting to the Manager, Quality Assurance (QA) Capability, theSeniorQA Associate is responsible for the following:
Review and approval of GXP documentation and Quality process change controls to ensure compliance with regulatory requirements and the approved processes;
Oversee and facilitate the Risk Assessment Process to support the busines;
Assist with and facilitate the Change Panel Process;
Assist with the management of compliance activities and provide validation advice and guidance for projects in line with relevant regulations and guidelines and review.
Selection Criteria
Tertiary qualification in Science /Computer related field;
Experience in pharmaceutical manufacturing is preferred however 2-3 years in a similar regulated industry with a focus on QA & cGMP will also be considered;
Experience and demonstrated understanding of Regulatory Standards (TGA, FDA and ISO-13485), Quality Risk Management, Quality Control and GMP requirements;
Experience and knowledge in the application of Quality Systems including IT systems and system validation;
Excellent interpersonal and communication skills including presenting and negotiating;
Demonstrated attention to detail and ability to think analytically;
If you are looking to develop your skills and shape the health of Australians, please apply with your resume and cover letter, which must address the selection criteria above, and include the reference numberR-089135.
Applications will close on Tuesday 26th March 2019
CSL advises that screening including; criminal history, medical assessment, confirmation of experience, stated qualifications and other relevant checks form a part of the candidate suitability evaluation process. Where applicable, this applies to current CSL employees. CSL employees must notify their current manager when selected for interview for any advertised internal vacancies.
Important notice to Employment businesses/ Agencies
Seqirus does not accept unsolicited referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Seqirus' Talent Acquisition to obtain prior written authorization before referring any candidates to Seqirus. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Seqirus. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Seqirus. Seqirus shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
