Validation Lead job vacancy in Boston, Massachusetts ASCII Group LLC

Vacancy expired!

Title :

Validation Lead

Location :

Boston, MA

Duration : 12 Months

Rate : Negotiable

Visa Status : Any work Status – Except OPT & STEM

In-Person Interview : No

Relevant Experience (in Yrs) 12+

Technical Skill Set• Should have worked on Life Science Computer System Validation, Risk Based Validation Approach• Good experience in GxP Verification and Validation • Should have experience in creating Validation Master Plan, defining Validation strategy, IQ, OQ, PQ and Risk Analysis• Should have good hands-on validation testing experience including leading and defining Validation Strategy• Should be able to independently deliver validation lifecycle deliverables for projects with minimum supervision• Knowledge of 21 CFR Part 11 for Electronic Records and Electronic Signatures • Good experience with SDLC and STLC• Should have good understanding of project lifecycles and the comprehensive delivery process for GxP systems.• Should have extensive exposure to Change Management process.• Extensive Domain knowledge of Life Sciences/ Pharma domain.• Excellent communication skills, leadership qualities, systematic approach and ability to work under time and resource constraints.• Good understanding of ITIL process.• Involved in direct client interaction.• Competent in conflict management and escalation handling.• Preferably have experience working in validation of Serialization systems- preferably Arvato CSDB and Axway serialization systems

Technical Responsibilities:• Should have good experience in Computer System Validation, Risk Based Validation Approach, Alignment with GAMP 5 standards• Good experience in writing Validation Plans, undertaking Risk Assessments, defining Validation strategies, educating teams on GxP approaches and supporting implementations, writing Validation Summaries.• Excellent communication and stakeholder management responsibilities• Good understanding of Change Management process (preferably using ServiceNow)• Good experience with Validation Testing practices in GxP environments• Experience with validating and qualifying Cloud based systems• 21 CFR Part 11 for Electronic Records and Electronic Signatures • SDLC and STLC, Verification and Validation for GxP systems • Should have good understanding of project lifecycles and the comprehensive delivery process.

Must Have Technical Qualifications: End to End Computer System Validation, Validation of Serialization systems, GxP testing, Knowledge of 21 CFR Part 11, 210,820, Change Management methodologies

Must Have Business Qualifications: Competent in conflict management and escalation handling, Validation deliverable Management, Excellent Communication

Nice to Have Qualifications: Validation of IT Infrastructure, Validation of Supply Chain Management systems or Packaging systems

Key Responsibilities• Plan, own and manage end to end Validation activities for enterprise level system implementations and relevant upgrades – including but not limited to Serialization systems• Be the primary SPOC for giving directions to external vendors on adhering to corporate quality standards• Perform Risk Analysis, Quality Planning, Deliverable life cycle Management, as well as be the focal point of all validation management activities• Play the role of primary SME for Business and Technical teams on Validation strategy and implementation • Develop Validation Master Plan, Validation Strategy and coordinate with various stakeholders for IQ, OQ and PQ.• Manage and own validation testing including leading and defining GxP Testing Strategy• Educate different groups on GxP processes during project execution including alignment with SOPs and the processes to be followed• Work on Testing strategy with co-located/remote teams and follow STLC lifecycle to ensure testing is completed as per processes• Coordinate with Quality Control/CSQA to ensure adherence to corporate and regulatory standards• Coordinate with relevant stakeholders to ensure adherence to and implementation of Change management methodologies Thanks and Regards,

Rama Kishore Reddy=ASCII Group, LLC38345 W 10 Mile Rd, Suite 365, Farmington, MI 48335Direct| Email: Website: www.asciigroup.com https://in.linkedin.com/in/ramakishorereddy=v\: {behavior:url(#default#VML);}o\: {behavior:url(#default#VML);}w\: {behavior:url(#default#VML);}.shape {behavior:url(#default#VML);} Normal 0 false false false EN-IN X-NONE X-NONE MicrosoftInternetExplorer4 / Style Definitions / table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman",serif;}

Vacancy expired!

ID	#12234341
State	Massachusetts
City	Boston
Job type	Contract
Salary	USD Depends on Experience Depends on Experience
Source	ASCII Group LLC
Showed	2021-04-14
Date	2021-04-12
Deadline	2021-06-11
Category	Et cetera
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Job Details

Validation Lead

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