Katalyst Healthcares & Life SciencesDanvers (MA), 17 mi from Boston
in the pharmaceutical industry.
Experience leading SAS programming projects in the pharmaceutical industry.
Some experience with R is beneficial, but not required.
Experience with CDISC Foundational Standards, especially SDTM and ADaM
Experience creating Define.XML...
Artech LLCBillerica, 16 mi from Boston
Bachelor of Science Degree in Mechanical Engineering, Packaging Science, or similar discipline.
Years’ Experience Required:
Minimum of 5 years in medical device or pharmaceutical industry in Manufacturing Engineering, Packaging or Quality Engineering...
SSI PeopleCambridge, 4 mi from Boston
Knowledge of pharmaceutical industry and Project management experience within Medical Affairs, Clinical Research, Regulatory, CMC, Marketing or other drug development related function
• Knowledge of the drug development and commercialization process...
Booz Allen HamiltonLexington
Technical Program Manager, Lead. Design, implement, and maintain strategic, multi-disciplinary IT programs in support of corporate strategy. Knowledge of establishing and documenting repeatable programmatic and te. Our offerings include health, life, disability, financial, and retirement benefits, a...
AKIMABoston
The Program Manager leads project workstreams for a complex Air Force Enterprise IT modernization effort that delivers Software-Defined Wide Area Network (SD-WAN) and Secure Access Service Edge (SASE) solutions. Act as the single point of contact for all SD-WAN and SASE Original Manufacturers (OEMs)...
Abacus Technology CorporationHanscom Air Force Base
Knowledge of support activities that assist the program manager in assessing what programs are within schedule and cost baselines, be able to recommend viable solutions to problems, and the pursuit of alternative courses of action. Abacus Technology is seeking a Program Manager to provide acquisitio...
Proclinical StaffingBoston
and developing companion diagnostic (CDx) for precision therapies. We welcome individuals with expertise in precision oncology/rare diseases and a knack for collaboration and innovation.
Skills &Requirements:
• PhD or MD with broad bio/pharmaceutical industry...
Kojin TherapeuticsBoston
therapeutics that specifically modulate ferroptosis -- a newly discovered form of programmed cell death. Kojin is backed by a strong syndicate of top-tier investors, led by an experienced biotechnology and pharmaceutical-industry leadership team, and driven...
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Validation Expert
Katalyst Healthcares & Life Sciences | Boston | www.resume-library.com |
Responsibilities:
Understand and able to review vendor Qualification document package in line with regulatory requirements.
Knowledge of System and Functional Risk assessment / management, defining risk mitigation plan.
Should have good Stakeholder management skills to interact with customer, business, and vendors efficiently.
Subject matter expertise in areas such as Quality Management, Document management, Software Development Life Cycle, Configuration Management and Change Management.
Should have good knowledge on Chromeleon LabVantage LIMS and Scitara, should have good understanding of Labvantage Scitara and Chromeleon integration works.
Should be able validate integration between two applications (Chromeleon and Scitara).
Should be able to author test scripts for Chromeleon and Scitara integration.
Review test scripts for Labvantage LIMS , Chromeleon, SoftMax , Scitara and Labx.
Know how on Equipment and Instrument qualification process and regulations.
Knowledge on Analytical lab instruments like CDS systems, Labx instruments and SoftMax plate reader.
Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT, Data Privacy, Data Integrity, and Information Security.
Ensure Compliance of Equipment in accordance to GxP regulations and customer QMS policies and procedures across Equipment Lifecycle.
Knowledge of various Validation tools and templates used throughout the pharmaceutical industry.
Knowledge and hands on experience conducting periodic review.
Knowledge on new regulations -Enable innovations, Quality by design, CSA.
Technical Writing Experience.
Basics of project leading skills
Requirements:
Excellent communication (oral and written) and attention to detail.
8 to 10 years Lifesciences, should have analytical instrument and applications exposure.
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
Excellent knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11.
Excellent knowledge of computer system validation and GAMP -5 standards.
Understand and able to review vendor Qualification document package in line with regulatory requirements.
Knowledge of System and Functional Risk assessment / management, defining risk mitigation plan.
Should have good Stakeholder management skills to interact with customer, business, and vendors efficiently.
Subject matter expertise in areas such as Quality Management, Document management, Software Development Life Cycle, Configuration Management and Change Management.
Should have good knowledge on Chromeleon LabVantage LIMS and Scitara, should have good understanding of Labvantage Scitara and Chromeleon integration works.
Should be able validate integration between two applications (Chromeleon and Scitara).
Should be able to author test scripts for Chromeleon and Scitara integration.
Review test scripts for Labvantage LIMS , Chromeleon, SoftMax , Scitara and Labx.
Know how on Equipment and Instrument qualification process and regulations.
Knowledge on Analytical lab instruments like CDS systems, Labx instruments and SoftMax plate reader.
Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT, Data Privacy, Data Integrity, and Information Security.
Ensure Compliance of Equipment in accordance to GxP regulations and customer QMS policies and procedures across Equipment Lifecycle.
Knowledge of various Validation tools and templates used throughout the pharmaceutical industry.
Knowledge and hands on experience conducting periodic review.
Knowledge on new regulations -Enable innovations, Quality by design, CSA.
Technical Writing Experience.
Basics of project leading skills
Requirements:
Excellent communication (oral and written) and attention to detail.
8 to 10 years Lifesciences, should have analytical instrument and applications exposure.
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
Excellent knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11.
Excellent knowledge of computer system validation and GAMP -5 standards.
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