Job Description

Designation

Contractor

No. of Positions

1

Experience

7.5-12 Years

Skill (Primary)

Domain Competencies (APPS)-Pharma Validation & Verification-Computer System Validation (CSV)

Qualification

B Tech

Expected Date of Closure

30-Sep-2023

Job Family

Practice (Digital)

Employee Group

Contract

Job

Technical Architect

(Posting).

New Billing/ Exclusive/ Committed CSV SpecialistCSV, 21 CFR part 11, Data integrity, Archiving Provide compliance leadership, direction and oversight to project teams in the area of Computer System Validation Responsible for the quality oversight of GxP regulated computerized systems (e.g. manufacturing plant systems, laboratory systems and enterprise applications). Manage the release of regulated systems for GxP production use Participate in the review and approval of technical changes, Quality Incidents, CAPA s and procedures Contribute to establishing and deploying processes, compliance-driven standards, and procedures (as required), determining boundaries for harmonization and alignment versus differentiation, and ensuring they remain current with FDA and global regulatory requirements for GxP computerized systems Participate in evaluating the current Crucell quality systems for GxP computerized systems, and implement improvements to comply with the current FDA/EU standards Provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 210, 211, 58, 820, 11 and EU Annex 11 EU) In addition, this individual will lead and participate in project teams and may participate in regulatory inspections and client audits Minimum Qualifications: Bachelor s or Masters degree in science, computer science, or relevant area English, fluently spoken and written Thorough knowledge of cGMP, in manufacturing and R&D within GxP regulated industries A minimum of 7 years relevant working experience in a pharmaceutical or biotechnology company of which preferably 3 years in validation or QC, and in QA/CSV In-depth knowledge of computerized quality systems Experience with GMP inspections Competences: Communicative skills Negotiation skills Convincing Team player Accuracy Problem solver (1.) To implement best practices by enforcing coding standards and knowledge up-gradation to work with new technologies so that the solution is current and meets quality standards as well as client requirements. (2.) To gather specifications and deliver solutions to the client organization based on understanding of a domain or technology. (3.) To train and develop team so as to ensure that there is an adequate supply of trained manpower in the said technology and delivery risks are mitigated. (4.) To architect, design and develop [through team] solution for product or sustenance delivery by communicating system requirements to software development teams, assisting team with solving technical problems when they arise and ensuring implementation of agreed architecture.

HCLTech