Senior Validation Scientist
Roche
Cape Town,Western Cape,South Africa,
1d ago
  • Job facts
  • ESSENTIAL RESPONSIBILITIES :

    Manufacturing Upscaling

  • A key focus for the role is the optimization and scaling up of processes obtained from development and successfully transferring the process into operations.
  • The role will be a key interface or bridge between development and operations, and will work with RUO products as well as products manufactured for IVD manufacturing sites.

  • Develop and document validation procedures and prepare associated documentation (Scale-Up Validation Plans, Validation protocols, SOPs, Work Instructions, Manufacturing Instructions and Forms) for scale-
  • up production or improvement of enzymes, bulk solutions, and aliquoted product (filling processes).

  • Characterize and trial new processes to ensure product attributes, acceptance criteria and process capabilities are adequately defined and developed.
  • Transfer new validated processes / practices to manufacturing staff through training.
  • Assist in developing compliant ancillary procedures / practices to facilitate scale up routine manufacturing,
  • Educate key stakeholders on validated processes, scale-up manufacturing, bulk solutions, aliquoted products, etc.
  • Designing validation sampling / test plans.
  • Executing validation studies.
  • Preparing Validation Reports (as applicable).
  • Resolving technical issues encountered during study execution.
  • Tracking and expediting the review and sign-off of validation documentation.
  • Drive completion of protocols and qualification according to deadline.
  • Supplier coordination. Obtain quotes from Supplier in regards to new equipment / utilities / consumables needed for process optimization.
  • Development and execution of equipment qualification and process validation protocols, liaising with relevant service providers.
  • Problem solving

  • Participates in troubleshooting a wide range of problems which requires creative thinking. Exercises significant technical discretion in design, execution, and interpretation, and pursues new validation / qualifications studies as a result of experimental outcomes.
  • Document Review

  • Review protocols and SOPs written by other validation team members.
  • Manage QA Systems

  • Raise CAPAs, NCRs and Change Requests where required and assist with investigations.
  • Manage validation workload arising from unscheduled events.
  • Assist during internal and 3rd party audits with regards to validation requirements by interacting with auditors during inspection or audits.
  • Internal Assessments

  • Validation documentation is written with all required detail and reviewed with few / no changes from reviewers. Standardised, agreed upon, document reference system is in place for validation protocols.
  • Provide training and support to new / current validation colleagues with respect to orientation and familiarisation with operations in the department.
  • Relationships

  • Establish, nurture and maintain good working relationships with internal and external stakeholders through regular communication, networking and attending relevant meetings.
  • Team Culture and Performance

  • Build a team culture of excellence, exceptional work ethic, superior quality of work and collaborative team spirit.
  • Employee Satisfaction

  • Recommending appropriate measures to address areas where satisfaction is found to be low / poor
  • Communication

  • Communicate the status of validation to the business on a regular basis.
  • Communicate progress and any delays / issues / changes experienced to the Validation Manager timeously.
  • Communicate with departments with regards to validation planning and time needed on systems / in facilities.
  • Provide guidance to staff from other departments with regards to the required content of procedures.
  • Communicate as frequently as possible to ensure that all stakeholders are informed at all times
  • MINIMUM QUALIFICATIONS :

    Formal Training / Education :

  • Science or Engineering diploma / degree; or certificate in a scientific discipline.
  • Experience

  • Minimum five years demonstrable experience related to the upscale e.g. bulk solutions, aliquoted product (filling processes) etc.
  • Experience in the upscale of enzyme manufacturing will be advantageous.

  • Minimum of three years’ previous process validation experience;
  • Validation experience in equipment, utilities, facility, process, cleaning, test method and computer validation will be advantageous
  • Must be from the diagnostic / pharmaceutical / biotech industry.
  • Knowledge, Skills, and Abilities :

  • Ability to communicate effectively at all levels in verbal and written form, including technical / business writing.
  • Able to work independently and multi-task.
  • Working knowledge of ISO Quality Management systems would be preferred.
  • Personal Competencies : Work independently or in collaboration with others, strong work ethic, communication skills, Planning and organizing, problem analysis and solving, effective time management, accountability.
  • Interpersonal Competencies : Good communicator, team player, change management, motivating, professionalism.
  • Managerial competences : Sense of urgency, assertiveness.
  • TRAVEL REQUIREMENTS : n / a

    n / a

  • Who we are At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-
  • focused healthcare groups. Our success is built on innovation, curiosity and diversity.

    Roche is an equal opportunity employer.

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