ESSENTIAL RESPONSIBILITIES :
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.
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.
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.
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.
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.
Recommending appropriate measures to address areas where satisfaction is found to be low / poor
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.
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
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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.