Search Results: 231 vacancies
$100k - $140k
...oversight activities for analysis of clinical trial data, ensuring quality and timeliness; prepare deliverables for regulatory submission to FDA/EMA/PMDA or other agencies (e.g. eCRTs, ISS, ISE, BIMO, P21 checks) and provide support for regulatory questions; perform statistical...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
$110k - $160k
...in compliance with Health Authority requirements; Provide regulatory assessments for change controls for various markets such as US FDA, EMA, Health Canada as well as liase with in-country regulatory representative to provide the assessments. Up to 20% remote work allowed...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
...component material etc.); analytical development studies for pMDIs and DPIs following cGMP, EH&S and other relevant guidelines of Lupin, FDA and other governing bodies.
Supervise and lead the execution of analytical activities required for regulatory submission including...
Suggested
...operating condition
~ Responsible for all aspects of HVAC and refrigeration equipment maintenance while complying with cGMPs, SOPs, and FDA requirements
~ Performs routine and complex work related to troubleshooting, repair, and upgrade of HVAC and refrigeration...
Suggested
Day shift
...and perform all functions associated with commercial and clinical manufacturing and packaging and assures compliance to GMPs, SOPs, FDA, DEA and OSHA rules and regulations.
Oversees unit operations consisting of and not limited to Hot Melt Extrusion, Fluid Bed, high...
Suggested
Holiday work
Permanent employment
Full time
Local area
Worldwide
Shift work
Afternoon shift
Monday to Friday
...Familiarity with the use of balances, pipettes, and HPLCs in the laboratory.
~ Demonstrated work experience in compliance with cGMP and FDA requirements, including Good Documentation Practices (GDP).
~ Experience in reviewing data for accuracy and compliance with...
Suggested
Hourly pay
Temporary work
Work experience placement
Immediate start
Worldwide
Flexible hours
...policies for quality control.
11. Maintains knowledge of current government and industry quality standards including but not limited to FDA, ISO, global standards, etc.
12. Responsible for all government reporting and filings regarding the facility or for permit renewals...
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...in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. She/he operates and maintains various pharmaceutical packaging equipment as assigned, and...
Suggested
Temporary work
Immediate start
Shift work
Afternoon shift
...pharmacy.
18.Serves as the Recording Secretary to the Institutional Review Board Committee. Prepares agendas and minutes. Adheres to all FDA regulations concerning investigational protocols of new drugs.
19.Responsible for the affiliation between the Ernest Mario School...
Suggested
Work experience placement
...in oncology
· Experience with PV audit process with active participation in Regulatory Authority Inspections; and working with the FDA and other regulatory authorities
· Experience with global PV regulatory environment (regulations, initiatives, standards, GVP); MedDRA...
Suggested
Fixed term contract
Remote job
...with clinical trial data
Advanced knowledge in industry standards, such as the ICH guidelines, CDISC standards, 21 CFR Part 11, and FDA guidelines
Experience in handling and processing upstream data, e.g., EDC, eDT, SDTM, and in providing outputs to meet downstream...
Suggested
Permanent employment
...Investigation Review Meetings (FIRM).
Supports product recalls and executes plan as assigned.
Represent Company during FDA/other regulatory inspections and corporate GMP compliance audits as defined in related Quality Agreements.
Assist with...
Suggested
Contract work
Remote job
...methodologies, including Agile, Scrum, Waterfall, etc.
Familiarity with life science industry standards and compliance requirements (e.g., FDA, ISO, GMP) is highly desired.
Excellent leadership and team management skills, with the ability to motivate and guide cross-...
Suggested
Local area
Remote job
Flexible hours
...Strong Communication Skills both oral and written- Savy in electronic systems as well
Requires knowledge of Quality Systems, FDA GxP regulations and guidance for pharmaceutical manufacturing.
Requires excellent verbal/written communication, negotiation/...
Suggested
Contract work
Remote job
...validation batches are manufactured as per the protocol requirements.
Skills:
Understand the quality and safety requirements per the FDA regulations and SOPs.
Follow all defined SOPs.
Communicate work-related issues and details effectively with the supervisor and...
Suggested
Day shift
Afternoon shift
Monday to Friday
...Special knowledge or skills needed and/or licenses or certificates required
Experience working with Food and Drug Administration (FDA), current Good Laboratory Practices (cGLPs), cGMPs, SOPs and regulatory rules, regulations and guidelines
Hands on experience performing...
Work experience placement
Local area
Immediate start
...and ensure operational execution of global and US submission activities. You will be responsible for interfacing directly with the US FDA as the primary contact for the company for assigned programs.
This position is based in our Princeton, NJ office which requires...
Fixed term contract
Remote job
...good industry practices for C/Q/V services, and regulatory requirements. You may also perform standalone commissioning services for non-FDA-regulated clients.
What You'll Do
Write C/Q/V documents following established standards and templates, including but not...
Work alone
Night shift
...as analytical methods, specifications, Method Validation/Transfer Protocols and Reports, SOP's accordingly to company's standards and FDA /ICH guidelines, CAPAs, Lab Event/Out-of-Specification and Out-of-Trend investigations. To review the USP and other compendia changes...
Temporary work
Local area
Immediate start
Flexible hours
...conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and FDA/ICH regulatory requirements is essential.
The position involves working closely with the Sr. Director of Clinical Research Operations...
Contract work
Flexible hours
Shift work
