Reports to : Senior Manager, Technical Services and Validation
Snr/Validation Specialist (Drug Product)
Reports to : Senior Manager, Technical Services and Validation
Objectives:
Carry out qualification/validation activities associated with the manufacture of biologics and vaccines at the clinical manufacturing facility, focusing on Drug product fill and finish line
Responsible for completing milestones related to validation deliverables such as commissioning, qualifications, equipment PQ’s and cleaning/shipping/process validations and validation maintenance
Responsibilities:
Develop qualification/validation documents such as concept/strategy/plan, protocols, report and SOP’s whenever required, particularly in the area of final fill finish equipment, gmp mixers, autoclave, controlled temperature chambers (CTC’s) and various gmp direct systems
Execute thermal mappings for CTC’s, load preparation and autoclave PQ runs and BI/TC placements
Plan, execute Vaporised hydrogen peroxide (VHP) decontamination of fill finish equipment such as isolators and lyophiliser, manual cleaning development, engineering and water runs, aseptic media fill (AMF) and aseptic process simulation (APS) of fill finish systems (isolator, filling, stoppering, capping)
Cleaning method development and verification for Grade A isolator including but not limited to cleaning approach and strategy, cleaning risk assessment, sampling rationale such as (cleanability , surface classification, MOC assessment, sampling locations, and hold time justification and calculation of residual acceptance limits (product residue, cleaning agent and carryover)
Solve various challenges during equipment, cleaning, sterilization and process qualification/validation by proposing solutions to overcome them, conduct RCA, CAPA, change control in timely to meet project and operational schedule
Coordinate with internal stakeholders (manufacturing DS and DP, facility and engineering, quality validations, operations and compliance as well as external stakeholders such as equipment vendors, rental providers and external testing labs for sample taking, preparation, submission and results
Plan, deliver re-/qualification /validation activities and milestones according to project and production schedules
Generate and maintain all qualification/validation activities in an inspection ready status ahead of any internal and external audits to ensure successful inspections ie. no critical observation related to qualification/validation activities – act as validation SME during regulatory audits/inspection
Ensure qualification/validation related training requirement is met and up to date
Education, Behavioural Competencies And Skills:
BSc/MSc in an engineering/scientific discipline (Bio/chemical/mechanical engineering/life science/biology/chemistry) with a minimum of 2-6 years relevant industry experience
Knowledge/experience in Drug Product (DP)/fill and finish equipment qualification/validation activities, aseptic filling /process simulation (APS), Vaporized hydrogen peroxide (VHP) decontamination cycle development and PQ activities such as GMP mixers PQ, isolator PQ, smoke studies, filling, stoppering and capping machines PQ
Experience in machinability evaluation, CCIT will be added advantages.
Experience in project coordination, management of internal and external stakeholders in qualification related documents, protocols review, approvals
Experience in authoring, executing, reviewing and approving qualification/validation protocols and report in support of facility /equipment commissioning, qualification/validation.
Experience in raising exceptions/deviations during qualification/validation, perform investigations and utilise various root cause analysis tools in driving the closures in timely manner.
Hands-on experience in technical execution of validation tasks associated with cleaning verification/validation, sterilization validation (ie autoclaves) and its sterile hold studies, controlled temperature chambers (CTC) like fridge and freezers, incubators using thermal mapping equipment like Kaye validators, Biological/chemical indicators handling and sample taking.
Experience in supporting regulatory agency interactions such as regulatory submissions, response and submission questions, pre-approval/scheduled inspections, and observational response plans
A thorough knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
Well-organized and detail-oriented, with ability to effectively prioritize tasks with agility, eager to learn, interact and collaborate effectively with various stakeholders in a team environment and consistently demonstrate reliability and responsibility
Must be a team player with good working ethics, initiative, diplomacy, positive influencing abilities and drive
Good oral communication and demonstrable, exemplary writing skills
Experience in clinical manufacturing validation is an advantage and not a must.
