Senior Validation and Compliance Lead

1 week ago

Bengaluru, Karnataka, India Allucent Full time

Job Title: Senior Validation and Compliance Lead

About the Role:

We are seeking a highly skilled Senior Validation and Compliance Lead to join our team at Allucent. As a Senior Validation and Compliance Lead, you will be responsible for leading the validation and compliance activities within Technology & Innovation assigned projects. This includes controlling and monitoring the validation and compliance status of GxP impacting systems, ensuring planning, preparation, and execution of validation and testing activities in accordance with standard operating procedures, regulatory guidelines, executed client contracts, and clients' expectations.

Key Responsibilities:

  • Develop and implement a CSV strategy.
  • Support the lifecycle of computerized system validation activities.
  • Participate in risk assessments to help identify and mitigate compliance risks.
  • Work with IT, QA, and functional teams to integrate validated systems into daily operations.
  • Maintain CSV documentation and assist in staff training.
  • Stay informed about technological advancements and regulatory changes.
  • Assist in audits related to computerized systems and support corrective actions.
  • Contribute to continuous improvement by recommending process enhancements.
  • Assess IT controls and processes for alignment with policies and procedures.
  • Support the development of the Risk Management Framework and Data Governance standards and processes.
  • Guide teams to leverage data integrity controls to ensure data accuracy, security, consistency, and reliability throughout its lifecycle.
  • Actively contribute to staff learning & development within the Company.
  • Provide and coordinate Validation Testers training for relevant staff.
  • Review, improve, and evaluate processes and procedures within the Quality Management System.
  • Ensure that all processes and systems meet quality standards and regulatory requirements.
  • Support audit and inspection readiness by maintaining accurate and complete validation and compliance documentation.
  • Actively participate in the resolution of audit/inspection findings and associated CAPAs.
  • Assure strong long-lasting relationships with key accounts.
  • Support in the preparation of new proposals.
  • Contribute and take part in client evaluations, visits, and bid defences.

Requirements:

To be successful, you should possess:

  • Degree in Computer Science, Information Technology, Life sciences, or a related field.
  • Minimum of 5 years of experience in computerized system validation within a CRO, pharmaceutical, or biotechnology environment.
  • Thorough knowledge of GxP, GAMP 5, 21CFR11, EudraLex V4 Annex 11, and other applicable regulations.
  • Strong analytical and process-oriented skills.
  • Proficiency in Computer System Validation and managing testing teams for user acceptance testing.
  • Strong written and verbal communication skills, including a good command of the English language.
  • Representative, outgoing, and client-focused.
  • Ability to work in a fast-paced, challenging environment of a growing company.
  • Administrative excellence.
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint.
  • Strong leadership skills.
  • Effective at problem-solving, strategic thinking, and conflict resolution.
  • Strong presentation and networking capabilities.
  • Excellent organizational, negotiating, and financial skills.

Benefits:

Benefits of working at Allucent include:

  • Comprehensive benefits package per location.
  • Competitive salaries per location.
  • Departmental Study/Training Budget for furthering professional development.
  • Flexible Working hours (within reason).
  • Opportunity for remote/hybrid working depending on location.
  • Leadership and mentoring opportunities.
  • Participation in our enriching Buddy Program as a new or existing employee.
  • Internal growth opportunities and career progression.
  • Financially rewarding internal employee referral program.
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms.
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects.
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees.

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