Melbourne, Victoria, Australia · On-site
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Quality Management Systems, cGMP, e-PQS, MasterControl, BlueMountain
Melbourne, Victoria, Australia · Remote OK
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Melbourne, Victoria, Australia · On-site
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Skills: Radiation Therapy Planning, Treatment Simulation, EBRT, DIBH, IMRT
Melbourne, Victoria, Australia · On-site
$2k–$3k/wk
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Melbourne, Victoria, Australia · On-site
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Melbourne, Victoria, Australia · Hybrid
$61k–$73k/yr
Acknowledgement of Country CSIRO acknowledges the Traditional Owners of the land, sea and waters, of the area that we live and work on across Australia. We acknowledge their continuing connection to their culture and pay…
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Melbourne, Victoria, Australia · On-site
Company Description Consider joining Eurofins PSS® where people are the most important element in our business. Eurofins PSS® is the global leader of scientific insourcing services. PSS® is not only a leader in the indus…
Skills: QC Microbiology, Environmental Monitoring, GMP Compliance, Aseptic Technique, LIMS
Melbourne, Victoria, Australia · Hybrid
Company Description Work with Us. Change the World. At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work he…
Skills: Environmental Impact Assessment, Project Management, Client Engagement, Business Development, Technical Leadership
Melbourne, Victoria, Australia · Hybrid
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Melbourne, Victoria, Australia · Hybrid
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Melbourne, Victoria, Australia · Hybrid
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Melbourne, Victoria, Australia · On-site
As the largest pureplay adhesives company in the world, H.B. Fuller’s (NYSE: FUL) innovative, functional coatings, adhesives and sealants enhance the quality, safety and performance of products people use every day. Foun…
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Melbourne, Victoria, Australia · On-site
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Melbourne, Victoria, Australia · On-site
Changing Lives, Transforming Careers At Amplifon, we’re more than a company. As the Global Leader in hearing care, we combine cutting-edge solutions with a personal touch to create unforgettable experiences for our custo…
Skills: Audiology, Clinical Work, Hearing Care, Patient Care, Customer Experience
Melbourne, Victoria, Australia · On-site
At Peter Mac we aim to continuously improve cancer care, research and education across all cancers and for all people affected by cancer: changing lives, breaking new ground. Everything we do is underpinned by our core v…
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Melbourne, Victoria, Australia · Hybrid
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Skills: Product Development, Technical Data Management, Specification Management, Food Safety, Good Manufacturing Practice (GMP)
Melbourne, Victoria, Australia · Hybrid
LocationMelbourne, VIC, Australia Casual Speech Pathologists – Early Communication Research Study Melbourne | Brisbane | Perth working remotely for Cerebral Palsy Alliance Research Institute Casual - This role is perfect…
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Melbourne, Victoria, Australia · On-site
$113k–$134k/yr
About VU: At VU, we aim to be one of the leading impact universities in the world. VU is an impact‑driven university committed to equity, excellence and opportunity. Based in Melbourne’s west and connected globally, we a…
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Melbourne, Victoria, Australia · On-site
Changing Lives, Transforming Careers At Amplifon, we’re more than a company. As the Global Leader in hearing care, we combine cutting-edge solutions with a personal touch to create unforgettable experiences for our custo…
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Melbourne, Victoria, Australia · Hybrid
$120k–$142k/yr
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Skills: Optical Sensor Technologies, LED Technology, Photodetector Technology, Surface Mount Device Components, Microfabrication
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Assist the Quality Assurance Manager in developing and maintaining the Quality Management Systems and e-PQS at the Melbourne site. Oversee compliance, manage GMP software systems, and lead people management responsibilities for direct reports.
Requires a Bachelor of Science, Pharmacy, or related degree with at least ten years of experience in cGMP pharmaceutical manufacturing or quality assurance. Must be proficient in e-PQS software and have experience with regulatory authority audits.
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Purpose:
Assist the Quality Assurance Manager in the overall development, maintenance, and continuous improvement of the Quality Management Systems at PCI Melbourne. Specifically, the compliance, management, training, implementation and updates of the PQS and e-PQS, and other GMP software systems requiring quality oversight (including but not limited to MasterControl and BlueMountain).
Maintain robust Quality monitoring (and the review of compliance to metrics) to ensure the assessment of an effective quality management system and the escalation of adverse trends.
Primary responsibilities:
Qualifications & experience:
Behavioural competencies required for this position:
#LI-AK2
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
CDMO. Inspired by tomorrow. Let's talk future™.
We are PCI Pharma Services. CDMO. Today’s Drug Development & Manufacturing, Advanced Drug Delivery & Drug Device Combination Products, Clinical Trial Services, and Commercial Packaging Technology. Inspired by tomorrow. We provide world-class solutions through intelligence, ingenuity and innovation, together, delivering life-changing therapies. Across 38 global sites and supported by more than 8,000 dedicated employees, we bring together leading technology and continued investment to deliver seamless solutions from development to commercialization, supporting our clients to improve the lives of patients worldwide.
Offices: 3001 Red Lion Rd, Philadelphia, PA 19114, US · 23 Commerce Dr, Bedford, New Hampshire 03110, US · 4545 Assembly Dr, Rockford, Illinois 61109, US · 6166 Nancy Ridge Dr, San Diego, California 92121, US · 977 Century Dr, Burlington, Ontario L7L 5J8, CA
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