Senior Specialist, Validation, QA

Major responsibilities

• Facility & Utilities Qualification (URS/DQ/IQ/OQ/PQ): Coordinate qualification of cleanrooms (ISO classes) HVAC process gases and PW/PS systems; ensure environmental monitoring programs are defined and validated.
• Equipment Qualification: Plan and witness the IQ/OQ/PQ for critical assets (biosafety cabinets incubators centrifuges isolator cryogenic freezers liquid nitrogen storage autoclave QC instruments) including communication and coordination with equipment suppliers or third-party validation service providers.
• Aseptic process stimulation: Organizing or coordinating aseptic process simulation.
• Third-party Validation Service: Responsible for reviewing validation or qualification protocols provided by suppliers assisting and supervising the implementation of supplier protocols and promptly reporting any problems discovered during implementation;
• Documentation & Compliance: Draft and maintain validation master plan (VMP) protocols reports SOPs and risk assessments (FMEA); ensure controlled documentation versioning and readiness for inspections.
• Risk Management: Conduct and maintain risk registers for sterility assurance crosscontamination and patient safety; implement mitigations and monitor effectiveness.
• Training & Qualification: Coordinate operator qualification for aseptic manipulations and critical steps; ensure ongoing competency assessments and deviation/error reduction initiatives.
• Deviation/CAPA & Change Control: Lead or support investigations for validationrelated deviations; define robust CAPAs; manage changes to facilities/equipment/processes/software with impact assessments.
• Audit & Inspection Readiness: As the validation SME to prepare the site for internal audits and health authority/customer inspections regarding to the validation; provide evidence packages walkthroughs and responses; drive closure of findings.

Education Qualifications Skills and Experience

• Education: Bachelors degree in pharmacy Life Sciences Biotechnology or related field; advanced degree a plus.
• Experience: 5 years in GMP cell therapy biologics or sterile manufacturing; proven track record in site startup and validation (facility/equipment/process); 2 years of experience as a validation project manager or team manager and having led qualification work; Experience with autologous or allogeneic workflows preferred.
• Technical Knowledge: Strong understanding of qualification and validation strategy aseptic processing contamination control EM programs sterility assurance closedsystem operations singleuse technologies.
• Regulations & Standards: Familiarity with CFDA GMPEU GMP (including Annex 1) PIC/SUS FDAguidance (cell therapy CGMP)ICH Q7/Q8/Q9/Q10GAMP 5ISO 14644ISPE Baseline Guides and data integrity (ALCOA).
• Skills: Familiar with the use of qualification instruments such as temperature verification instrument pure steam mass tester particle counter.
• Behavioral Attributes: Ownership urgency collaboration and a continuous improvement mindset; comfortable working in highstakes inspectionready environments.
• Logistics: Willingness to work onsite support offhours validation runs and travel to vendors/CMOs as needed.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.