To participate in all manufacturing process development activities, e.g. characterisation and validation and ensure that validation requirements are met for all existing and new equipment/facilities/utilities and processes.
- A key focus for the role is the optimisation 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 (Validation Plans, Validation protocols, SOPs, Work Instructions, Manufacturing Instructions and Forms) for production or improvement of enzymes, bulk solutions, and aliquoted product (filling processes).
- Characterise and trial new processes to ensure product attributes, acceptance criteria and process capabilities are adequately defined and developed.
- Assist in developing compliant ancillary procedures/ practices to facilitate routine manufacturing.
- 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.
- 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
- Initiate 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.
- 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.
- Science or Engineering degree.
- 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 organising, problem analysis and solving, effective time management, accountability.
- Interpersonal Competencies: Good communicator, team player, change management, motivating, professionalism.
- Managerial competences: Sense of urgency, assertiveness.
Roche is an equal opportunity employer.Quality, Quality > Quality Validation