Senior Specialist, Validation, QA at AstraZeneca

, , China -

Full Time

Start Date

Immediate

Expiry Date

02 May, 26

Salary

0.0

Posted On

01 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Facility Qualification, Utilities Qualification, Equipment Qualification, Aseptic Process Stimulation, Risk Management, Training, Deviation Management, CAPA, Change Control, Audit Readiness, GMP, Biologics, Sterile Manufacturing, Validation, Documentation, Collaboration

Industry

Pharmaceutical Manufacturing

Description

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, cross‑contamination, 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 validation‑related 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: Bachelor’s 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 start‑up 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, closed‑system operations, single‑use technologies. Regulations & Standards: Familiarity with CFDA GMP, EU GMP (including Annex 1), PIC/S, US FDA guidance (cell therapy, CGMP), ICH Q7/Q8/Q9/Q10, GAMP 5, ISO 14644, ISPE 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 high‑stakes, inspection‑ready environments. Logistics: Willingness to work on‑site, support off‑hours validation runs, and travel to vendors/CMOs as needed. Date Posted 01-Feb-2026 Closing Date 30-May-2026 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Senior Specialist will coordinate the qualification of facilities and utilities, plan equipment qualification, and manage aseptic process simulations. They will also oversee documentation, compliance, risk management, and training related to validation processes.