Overview
Pharmaron is excited to offer an opportunity for a CSV Technical Specialist to join our dynamic team at the Rushden Metabolism facility. In this pivotal role, you'll play a key part in ensuring our computer systems meet the highest standards of validation and compliance, aligned with GAMP 5, GLP, GCP, and internal quality expectations. If you're passionate about driving excellence in system integrity and compliance, we’d love to hear from you!
Responsibilities
* Responsible for managing projects related to computerised system validation and perform the data integrity assessments in Metabolism department.
* Write and execute the GxP system lifecycle documentation including the System Risk assessment, Validation Plan, User Requirements Specifications, Vendor Assessment, Configuration Specifications / Verification, Testing Protocols / Scripts, Risk Assessment, Traceability Matrix, User Acceptance Testing, Validation Reports, Compliance assessment and SOPs.
* Responsible for the systems, Instrument, software’s data integrity assessment.
* Solve the problems during the validation process and able to handle and close out of the incidents, deviations and change controls during the validation process.
* Actively collaborate with project stakeholders and the IT team to define the needs of projects.
* Ensure complete and accurate documentation of computerised system lifecycle is available, maintaining clear records and compliance.
* Ensure that system validation SOPs align with Regulatory Requirements and Industry standards.
* Participate in Sponsor and Regulatory Audits.
* Support the administration and operation of Computerised systems.
Requirements
* MSc or BSc in Chemistry/Biochemistry/ Biomedical Sciences or related subject or a qualification in Computer Science
* Working knowledge and good hands on the end-to-end CSV projects.
* Proficient Knowledge of CSV Principles and GAMP 5 requirements to facilitate changes and system improvements.
* Good understanding of the requirements of the Data integrity.
* Good understanding of the Laboratory systems, instrument, and software's. (Desired but not mandatory).
* Good understanding of the GLP and GCP Guidelines and Regulations. (Desired but not mandatory).
* Effective communication skills both written and oral are required to communicate with colleagues and a wider audience.
* Excellent computer literacy skills are essential as work will be heavily focused on software and applications
* Knowledge of quality/regulatory standards and quality systems (in particular the relationship of the MHRA with the pharmaceutical industry) is desirable.
About Pharmaron
Pharmaron is a premier R&D service company supporting the life sciences industry, with operations in China, US and UK and a workforce of over 21,000. Founded in 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development. With operations in China, US and UK staffed by over 21,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China.
Why Should You Apply?
* This is an opportunity for you as a CSV professional to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
* Build and shape your career in an environment that sets and commits to the highest standards of Chemistry.
* To be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.
Additional details
Seniority level: Entry level; Employment type: Contract; Job function: Information Technology; Industries: Pharmaceutical Manufacturing.
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