Hybrid CSV Specialist (Onsite / St. Joseph, MO) en ProPharmaGroup
ProPharmaGroup · United States Of America, Estados Unidos De América · Hybrid
- Oficina en United States Of America
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
This will be 100% onsite in St Joseph. MO
*** 𝐓𝐡𝐢𝐬 𝐫𝐨𝐥𝐞 𝐢𝐬 𝐧𝐨𝐭 𝐨𝐩𝐞𝐧 𝐭𝐨 𝐭𝐡𝐢𝐫𝐝-𝐩𝐚𝐫𝐭𝐲 𝐫𝐞𝐜𝐫𝐮𝐢𝐭𝐞𝐫𝐬 𝐨𝐫 𝐚𝐠𝐞𝐧𝐜𝐢𝐞𝐬. ***
Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports)
Experience in validating GMP Lab systems and Equipment
Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project.
Identify and escalate, as necessary project risks and issues to the CSV Manager.
Engage in multiple CSV projects through the assimilation of data, establishing facts and drawing valid conclusions to deliver results in accordance with resources, constraints and business needs.
Requirements
Prepare reports on defects and problems that arise during system testing.
Solid oral and written communication skills and teamwork skills.
Good team player, able to meet deadlines and handle changing priorities.
Strong judgment capabilities to clarify requirements when necessary.
Able to work with cross functional teams.
Solid experience working with validated systems.
Work with business representatives to ensure the test cases reflect business rules and processes.
Fulfills a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting client's business processes.
GMP/Regulated lab, more than 5 years of CSV experience required.
Technical writing experience.
Highly skilled in Computerized System testing and validation in the healthcare industry.
Knowledge of GxP regulations (e.g. 21 CFR Part 11, Annex 11).
Solid project organizational skills and able to multi-task.
Must have strong analytical problem-solving skills.
Self-motivated, detail oriented, takes initiative and able to work independently without close supervision.
Education: BS in Science or Technical Writing Degree
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***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
