QA Validation Specialist

The QA Validation Specialist performs review and approval activities to support validation activities in Alexion ARDU cGMP commercial and clinical requirements for the Alexion Manufacturing Facility. The responsibilities will include performing review and approval of validation documents such as policies master plans procedures specifications investigations protocols and reports.

• Maintenance of a strong Quality culture throughout the project through operational activities.

• Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.

• Lead and/or participate in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures policies and regulations.

• Participate in verification quality risk assessments and provide quality oversight to ensure

• verification quality risk assessments are effectively maintained/controlled.

• Ensure and participate in the Quality Assurance support to internal manufacturing and technical

• groups. Review and approval of functional area documentation (SOP Work Instructions

• Criticality Assessments technical report and protocols).

• Authoring review and approval of QA validation -related procedures.

• Review and approve Validation protocols as required. (Examples include cleaning process and method validation).

• Support the vendor quality management programme.

• Complete Audits as required.

• Develop and report quality metrics for validation/verification.

• Provide quality oversight of calibration and preventative maintenance criticality assessments as required.

• Interface with relevant departments to ensure compliance with corporate policies GMP and regulatory requirements.

• Primary Degree in Science

• Post-graduate studies as appropriate to augment primary degree

• 3-5 years experience in Quality/validation environment. Drug Product and Drug Substance experience

• Excellent attention to detail

• Good communication team work and problem solving skills

• The duties of this role are generally conducted in an office environment and in a pharmaceutical manufacturing environment.

• As is typical of an office-based role employees must be able with or without an accommodation to: use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and non-linear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

• As is typical of a pharmaceutical manufacturing-based role employees must be able with or without an accommodation to: frequently lift/carry 15/30 pounds unassisted/assisted; stand for prolonged periods of time; walk and move for prolonged periods of time; climb stairs or ladders; gown/degown PPE and uniforms; use a computer with a keyboard and mouse; collaborate with others; maintain general availability during standard business hours.

• Excellent interpersonal skills are required as is the ability to communicate well both verbally and written.

• Good knowledge of relevant computer packages e.g. Trackwise SAP and Vault Quality

Date Posted

Closing Date