Senior Specialist, Operation, QA for Manufacturing

Major responsibilities

• On shop floor quality oversight for cell therapy products to ensure product batch is manufactured according to approved procedure and in compliance with current GMP requirements
• Performs the QA review and approval of the following GMP documentation as it relates to the oversight scope to which the position is aligned:
  • Validation and Qualification documents
  • Deviation Investigation
  • Change control
  • Batch Records and associated documentation
  • Product and material Release
  • Others Quality Investigation (OOS Complaints etc.)
  • Standard Management Procedures
  • Standard Operating Procedures
• Leads and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
• Performs quality oversight of the utilities and facilities as per defined schedule
• Participate in project teams created towards problem solving or specific issues to ensure GMP and regulatory compliance
• Participate in internal self-inspection or other audit activities
• Support development and implementation of CAPAs identified from internal audits and regulatory inspection
• Participate in the development and implementation of Quality Risk Assessments related to utility and validation activities
• Participate in quality system reviews and provide appropriate data information
• Proactively participates in company initiatives toward continuous improvement (New Products Introduction GMP Improvement Programs etc.) while providing guidance in the area of knowledge and deliver timely results while contributing to quality system improvement
• Actively identifies develops establishes monitors and maintains area Key Performance Indicators (KPIs) as required. Take any action needed to prevent situations that may impact the patient safety quality of the product.

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 oversight. Experience with autologous or allogeneic workflows preferred.
• Technical Knowledge: Strong understanding of aseptic processing contamination control EM programs sterility assurance closedsystem operations singleuse technologies and risk-based decision making.
• 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: Excellent problem solving project management protocol/report authoring and reviewing risk assessment interpersonal and oral and written communication and meticulous documentation. Ability to deal with problems occurring in the field and make sound patientsafetyfocused decisions.
• Behavioral Attributes: Ownership urgency collaboration and a continuous improvement mindset; comfortable working in highstakes inspectionready environments.

Preferred/Optional

• Certifications: PMP Lean Six Sigma or GAMP qualifications.
• Tools: Experience with MES/eBR EMS/PMS QMS platforms.
• Logistics: Willingness to work onsite support offhours oversight 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.