QA Validation Specialist
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| Job Type | Contractor |
| Area | Dublin |
| Sector | QualityManagementLaboratory/ScientificOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2139 |
| Job Views | 531 |
- Description
- We are seeking applications for an experienced QA Validation Specialist our Clients Bulk Drug Substance (BDS) facility. In this role you will be responsible, with management support, for providing oversight of quality activities associated with the Quality Control dept. This responsibility includes the oversight of the site QMS related to QC to ensure that quality and compliance requirements are followed in line with business needs.
Why you should apply:
This is an opportunity to join a fast moving, rapidly growing entrepreneurial organisation that pursues its mission to transform patients' lives with persistence, dedication and perseverance. We are driven because we know their lives depend on it.
If you are Patient focused, like to challenge conventional thinking and enjoy collaborating to solve complex problems – then this is the company for you.
What you will be doing:
Provide Quality support to QC department to include method transfer or validation/verification activities.
LIR review and approval.
Provide oversight to continuous quality system improvements and support implementation of improvements in compliance, Calibration, Preventive Maintenance, Deviation Management and the Change Control Programs.
Perform review of change controls deviations and CAPA’s.
Provide QA and compliance support to projects impacting on Quality Control activities.
Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
Responsible for quality review and approval of Cert of Analysis in accordance with Alexion’s internal procedures and GMP principles.
Review and approval of company standard operating procedures and controlled documents.
Define and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to Quality Control Operations. Identify training needs and organize training interventions to meet quality standards
Coordinate and support on-site audits conducted by external providers
Evaluate audit findings and implement appropriate corrective actions
Monitor risk management activities
Assure ongoing compliance with quality and industry regulatory requirements
Draft quality assurance policies and procedures
Interpret and implement quality assurance standards and procedures
Evaluate adequacy of quality assurance standards
Devise sampling procedures and directions for recording and reporting quality data
Review the implementation and efficiency of quality and inspection system
What you need to apply:
Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility
Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
Demonstrated success records in auditing and improvement processes.
Ability to operate efficiently in a complex matrix organization and international environment.
Management skills for management of a team of experts.
Strong mature leadership and interpersonal influencing skills.
Ability to represent the company and to negotiate at different levels contacts both internally and externally.
Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
English fluency written and spoken (the Company language).
Efficient in SAP, firstdoc. and Track wise.
