This is what you will do:
TheSeniorSpecialist,Equipment and Systemsprimary focus will be supporting all QC Laboratoryequipment and systemsActivities.
This will include day to day routine maintenance and calibration activities for QC laboratory equipment,generation, and management of GMP documentation for all laboratory equipment which remain in avalidated state in the cGMP Laboratories at ADMF/APICOM.
This individual will be a high functioning, highly adaptable resource for theQCEquipment and Systems team andwill conduct activities in alignment with site SOPs and regulatory standards for
laboratory equipment qualification and maintenance.
You willbe responsible for:
• Daily instrument support
• Planning, executing, and documenting the PM/Cals on laboratory equipment released for use ina cGMP regulatory environment
•Accompanyingvendors (as required) to ensure all documentation generated as part routinecalibration/requalification is completed in a compliant manner
• Review and approval of PM/Cal validation documentation or reports
• Generation of tag numbers for equipment, introduction, and deactivation of work orders
• Conducting User access reviews on laboratory operating software
• Conducting Periodic review on laboratory operating software
•Ensure Audit readiness at all times
• Support any LEAN and CI lab activities and streamlining workshops
• Generation and resolution of protocol discrepancies, change controls and CAPAs asrequired.
• Generate SOPs as applicable.
• Ensure QAGs/SLAs are in place for all equipment vendors and contractors.
•Assistinadditionalduties as directed by the QCEquipment and SystemsManager.
• Working knowledge QC Lab systems and equipment
• Working knowledge and understanding of current regulatory requirements for cGMP laboratoryequipment
• The duties of this role aregenerally conductedin a lab environment. As is typical of a lab-basedrole, employees must be able, with or without an accommodationto:lift/carry 15/30 pounds
unassisted/assisted; work comfortably in a controlled environment with and around biological,infectious, and hazardous materials; gown/degownPPE; use a computer; engage incommunications via phone, video, and electronic messaging; engage in problem solving andnon-linear thought, analysis, and dialogue; collaborate with others; maintain general availabilityduring standard business hours.
We would prefer for you to have:
• A minimum of 3years experiencein a similar role
• A degree in chemistry, software, or an engineering related discipline
• Excellent technical competency in relation to instrumentation and equipment validation
• Skilled in organising, planning and priority setting along with strong time management skills
• Works very well in a collaborative manner
• Takes a structured, analytical approach to problem solving
•AI literacy to apply QC-relevant automation and analytics tools appropriately; data interpretation skills to translate AI-generated insights into scientifically soundoutputs,and strong digital/compliantjudgment tovalidateoutputs, manage data integrity, and ensureGxP/quality requirements are met.
Date Posted
28-Jul-2026
Closing Date
10-Aug-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.