Hiring for Sr. Validation Consultant in Andover, MA
ranjeet kumar
Hi,
please go through the job Description for Sr. Validation Consultant and send me your updated resume
Position : Sr. Validation Consultant
Location : Andover, MA
Duration – 12+months
Phone and Skype
Must have Lab Systems and Instrumentation experience
From the manager
· Absolutely need to have experience providing Quality oversight of laboratory systems and instrumentation. Contract manufacturing (CMOs) and/or contract labs (CTLs)
· They have a lot of work coming in, new equipment and vendors they are bringing in where this person will be providing quality oversight.
· Not writing of documents but overseeing all their contents.
· Rolling out new system design life cycles
· Data integrity is big. Make sure data is properly handled properly within FDA guidelines.
· Looking for someone who can help ppl understand why things are being done this way. Teaching vs telling.
· IT validation for new systems
· Long term contract as they have a lot of work coming in. Ira lives in Vegas but moved out here for this job.
Day to Day:
Our client is seeking and IT Validation Consultant
Responsible for ensuring GxP computerized systems are validated and controlled in compliance with local (e.g. 21 CFRT parts 11, 58, 210, 211) and international (e.g Eudralex and ICH Q7) guidelines. This individual will lead the qualification efforts in collaboration with IT using the SDLC of enterprise and server based applications supporting GxP operations. Additionally, the individual will be responsible for providing Quality oversight of laboratory systems and instrumentation qualification efforts.
Primary Responsibilities include:
Providing regulatory guidance for CSV policies and procedures for validation and data integrity.
Developing validation strategies for new or modified computerized systems.
Act as the Data Integrity (DI), CSV, and regulatory compliance subject matter expert (SME).
Facilitate the development and implementation of DI and CSV policies and procedures.
Works with system / business owners on DI and CSV assessment, qualifications and testing.
Review and approval of SDLC documentation including, but not limited to, SOPs, qualification protocols, gap assessments, risk assessments, impact assessments, user requirements, functional and configuration specifications, requirements and traceability matrices
Oversee CSV related change controls, deviations and investigations.
Uses risk management principles for qualification and remediation efforts.
Oversee the periodic qualification review and maintenance of computerized systems.
Lead and represent QA in multi-department project teams for CSV projects.
Provide audit support for CSV both locally and at CMOs/CTLs.
Serves as an SME of investigations and corrective and preventative action (CAPA) recommendations
Interfaces with Regulatory agencies as required representing company to authorities and regulatory inspectorates in matters relating to CSV
Provide regular updates directly to Management
Education and Skills Requirements:
8+ years of relevant experience and bachelor’s degree in science or related field. Biopharmaceutical or Pharmaceutical experience preferred
Direct experience working in CSV using FDA, ICH and GAMP guidance.
Knowledge and experience in CSV in highly regulated manufacturing environments
Must have in-depth understanding and application of GMP and validation principles, concepts, practices and standards in the US and internationally
Knowledge of biologics/gene therapy, chemical synthesis processes, analytical instrumentation desirable
Prior QA experience desirable
Able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories
Regards ,
Ranjeet Kumar | KPG99,INC
3240 E State,
St Ext | Hamilton, NJ 08619
609-400-4007 || ran...@kpgtech.com
Certified Minority Business Enterprise (MBE)