HOT REQ CSV( Computer System Validation) consultant @ Northridge, CA,

Please send resume to: asahu@precisesystems.com 

Dear Associates,

We have the below contract position with our client in . Please find the below J.D and if you have any consultant suitable with the requirement, feel free to submit the resume along with pay rate, visa details etc.

   

Greetings from Ashok, Precise Systems
 

Note:- Please submit photo id proof and visa copy is mandatory at the time of submission 

Duration of hiring is 6 months and may be extended.

Location is Northridge, CA, US

ROLE PURPOSE

Manage the Validation and Regulatory requirements for Pharma clients in such a way their Project deliveries are met.  Provide a high level of expertise and consultation to the Project Manager on Validation, Quality management and Project Deliverables.He/She would also be involved in BA activities as needed for the project success.

MAJOR ACCOUNTABILITIES

·         Understand and adhere to the Client Regulations/Processes, SOP on Project Management, Change Management, Document Management and Quality Management; and, Computerized System Validation concept with regards to document management, and V Model Methodology.

·         Support the Project Manager throughout the project delivery, with regards to aspects of project related risk, compliance and quality. 

·         Responsible together with Project Manager for the delivery of all defined Quality Management documentation

·         Pro-actively seek Project Manager input to develop sharing of necessary QM controls and validation of all QM Documentation

·         Maintain the project risk register for all ongoing projects, perform root cause analysis on trends and address deviations via preventive, detective and corrective measures to enhance PQM's deliverables and competencies.

·         Establish, implement and monitor the QM requirements which assures that IT Projects meet Quality and Regulatory requirements

·         Applies required internal and external Quality/Compliance standards to work products (Change control, validation documents etc.)

·         Ensure adequate analysis have been performed for relevant testing conditions based on functional risk assessment, test overview list, test plan, test results, test deviations and change requests.

·         Oversee the validation of the ICE deliverables

·         Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable

·         Manage appropriateness of preparation and readiness of the project for hand over of the system/processes to the operational organization together with the project managers

·         Perform the project tollgate/check point reviews and post implementation reviews with reporting to management

 

KEY PERFORMANCE INDICATORS / MEASURES OF SUCCESS

·         Able to manage direct relations with stakeholders and project team members

·         Proactive and result oriented

·         Dynamic, motivated self starter with excellent communication skills in English

·         Achievement of agreed targets in terms of quality and time

·         Achievement of service levels corresponding to projects standards

 

JOB DIMENSION

·         Manage the delivery of the QM project requirements

·         Manage the QM standards, Compliance Requirements and Controls end-to-end

·         Lead escalations and ensure remediation is prioritized and performed proactively

·         Host/Support GXP Audits

·         Location for this position is Germany.

 

EDUCATION / EXPERIENCE

·         12-15 years relevant work experience in IT/QM compliance

·         8 years' experience in Computer System Validation

·         Excellent English communication skills, both written and oral, additional languages would be a plus

·         GxP, 21 CFR Part 11 MUST  SOX, SOX IT, Data Privacy, IT Security knowledge would be a Plus

·         System Development Life Cycle and GAMP Knowledge

·         Knowledge in CoBIT, RiskIT, ITIL, ISO9000, PMBok, Six Sigma a Plus

·         Able to manage direct relations with stakeholders and project team members

·         PMP, CISA, ISO 9000 QMS certified etc. a Plus

 

Thanks....

Ashok Sahu

Precise | Consulting Services 

Email: asahu@precisesystems.com 
Phone +1.7037226071​

Fax +1.703.842.8775

--
You received this message because you are subscribed to the Google Groups " c2c jobs usa" group.
To unsubscribe from this group and stop receiving emails from it, send an email to c2cjobsusa+unsubscribe@googlegroups.com.
To post to this group, send email to c2cjobsusa@googlegroups.com.
Visit this group at https://groups.google.com/group/c2cjobsusa.
For more options, visit https://groups.google.com/d/optout.