Full Time

Validation Manager

Posted 2 months ago
Application ends: October 24, 2021
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Job Description

China, Guangzhou

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market.

As Validation Manager, you will be responsible for establishing the Validation set-up and team at the Guangzhou site. Provide leadership, management, oversight to day-to-day Validation Establish approved Validation SOPs/ Plans/ Policies for a small to medium scale single use, multi-product, GMP biotech contract manufacturing facility, establish deviations investigation protocols, policies and set-up with systems and people to ensure full cGMP compliance by operations launch.

Key Responsibilities

  • Provide oversight to day-to-day Validation activities in accordance with approv ed Validation SOPS/ Plans/Policies for a large scale, multi -product, GMP biotech contract manufacturing facility
  • Participate in review and approval of Validation Sops I Plans I Protocol s I Reports including site discrepancies and dev iations investigation I closure
  • Ensure implementation of Site Validation Maintenance Program and re- Validation requirements are performed in accordance with approv ed Site Policies I Plans I Sops
  • Monitor periodic reviews on trend analysis data for facility operating systems; identify issues and gaps, improvement strategies & generation of validation review reports
  • Develop strategy for performing and managing the validation programs to assure that the validation activities are scheduled and performed as needed
  • Perform & document detailed evaluation on critical validation processes and/or studies, including justification / rationale for approach, methodology, acceptance criteria and impact to product quality
  • Participate in dev eloping and managing department budget
  • Ensure proper implementation of Validation requirements in accordance with Site GMP Policy
  • Manage internal and external validation resources deployment to achieve department/ project goals
  • Lead / Particip ate in Regulatory Inspection / Customer Audits and provides responses to all validation related queries
  • Development/ implementation of departmental Plans / Policies
  • Leadership/managerial responsibilities for direct reports: examples include, provide leader ship to subordinates by directing, mentoring, coaching and developing them towards personal growth, enhanced job performance and career satisfaction
  • Support the analysis, and recommendation of solutions to process engineering challenges tied to Validation compliance and/or Facilities, Utilities, Equipment
  • Any other tasks as and when assigned by the superior

Key Requirements

  • BSc. in pharmaceutical Sciences /Biotechnology/equivalent
  • Practical experience in process support role on the shop floor of GMP manufacturing and/or QA/QC.
  • Familiarity with Regulatory requirements and local Codes & Standards (e. g. , FDA, EMA, GAMP , ICHQ7 , PDA and ISPE )
  • Good knowledge and experience of the practical and theoretical requirement of validation
  • Program in GMP facility
  • Good leadership skills
  • Strong interpersonal skills
  • Effective Communicator (oral and written)
  • Exhibit good quality decision making traits
  • Meticulous and Systematic
  • Analytical Mind
  • Ability to define specific goals clearly, to develop and prioritize activities
  • Team player, with str ong focus on safety, quality and timelines

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R37064

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