Search Results: 11 vacancies
...and care of the donor during the plasmapheresis process. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
**Key Accountabilities**
1. Follows all Standard Operating Procedures (SOPs) and regulatory policies and procedures, employee...
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Holiday work
Flexible hours
...resources. Coordinate interdepartmental process validation programs. Represent the department regarding process validation issues during FDA meetings and audits. Identify and resolve validation issues on a timely basis to avoid regulatory action and make recommendations to...
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For contractors
...Abilities
* Involvement in capital projects (new build/refurbishment of sterile lines) would be beneficial.
* Familiarity with U.S. FDA, EU Annex-1 and other regulations and guidance.
* Strong investigative skills, preferably familiar with Root Cause Analysis methods...
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...information for the mammography assistant for the breast history form and mammogram requests.
* Performs Quality Control (QC) needed for FDA/ACR.
* Maintains production and quality of 2D and 3D mammograms by following established standards and procedures; observing...
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Holiday work
Temporary work
Part time
Weekend work
2 days per week
3 days per week
Monday to Friday
...Quality Governance for the site
Managed the Pharma/Medical Manufacturing facilities integration following the compliance/ Validated (FDA) requirements aligning to the business needs and process guidelines.
Serve as the primary critical issue contact for local IT...
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Hourly pay
Permanent employment
Temporary work
Local area
Remote job
Flexible hours
...Catalent employee.
**The Role**
+ Ensure all batch records and logbook entries are accurately documented and compliant with SOPs and FDA cGMP guidelines.
+ Assist with setup, manufacturing, and changeovers with adherence to SOPs and safety requirements.
+ Other...
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Holiday work
Local area
Worldwide
Afternoon shift
...supply chain.
MRP knowledge and ERP experience in a cGMP manufacturing environment.
ISO or equivalent system and change control (FDA, cGMP) experience required.
Working knowledge of SAP is required.
Experience in sourcing of indirect services and materials....
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Temporary work
Local area
...required
+ Knowledge and understanding of the following principles and guidelines: EU EudraLex Volume 4 GMPs, 21 CFR Parts 111/210/211 (FDA), ISO, and related International Regulations affecting pharmaceutical products and medical devices
+ Sterile/biologic/ATMP/C...
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Holiday work
Local area
Worldwide
...safety of our patients and staff, employees in this role must be fully vaccinated, which may include a booster in some areas, with an FDA-approved COVID-19 vaccination.
**HOW WE HIRE**
Galileo is committed to hiring the best team possible to build health care that...
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Local area
...make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our focus...
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Local area
Flexible hours
Night shift
$90k - $100k
...over $1M.
Independently execute peer reviews for safety and quality of the product.
Produce control system design documents and FDA validation documentation per GAMP guidelines for the pharmaceutical industry.
Consultation with suppliers relating to sourcing,...
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For contractors
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