Quality Assurance Specialist (Engineering/Validation)

Position Summary

The QA Specialist for Validation/Engineering will be responsible, with management support, for providing oversight of quality activities associated with the Packaging/Serialization, Engineering, Validation, Automation for routine operations and new product introduction for Finished Product and Medical Device/Combination Finished Products.This responsibility includes the oversight of the College Park QMS to ensure that quality and compliance requirements are followed in line with business needs, including cGMP Biopharmaceutical and Medical Device quality standards.

This key role must ensure effective interaction the Operations, Engineering and CQV functions together with major stakeholders such as Artwork, NPI, Supply Chain, External Quality, QC, IT, QPs to ensure the reliable delivery of quality, safe, effective product to patients.

The position supports the clients Dublin Packaging on-site operations.

Principal Responsibilities

Provide QA support for Risk-Based Verification (RBV) and Computer Systems Validation (CSV) activities in the capacity of Quality Assurance Subject Matter Expert.

Review and approval equipment/utilities verification documentation from design to post execution.

Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.

Review and approve Validation protocols / reports as required.

Provide quality support for serialization of Finished Products

Support the vendor quality management program including generation and review of Quality Agreements

Provide oversight to continuous quality system improvements and support implementation of improvements at College Park in compliance, Preventive Maintenance, Deviation Management and the Change Control Programs.

Provide QA and compliance support to projects, including NPIs, for the clients Dublin packaging 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.

Provide Quality input, oversight and guidance to the clients deviations and investigations to ensure robust root cause analysis/CAPA definition and timely closure as per SOPs and QMS.

Provide Quality input, oversight and guidance to change controls, supporting risk assessments as required.

Review and approval of functional area documentation (SOPs, Packaging Instructions, Work Instructions, technical protocols and reports)

Leading actions assigned to College Park from complaints process

Define and report standard quality KPIs with recommendation for actions for improvement in relation to College park operations.

• Supporting right first time and continuous improvement from a systematic and compliance perspective
  

Requirements

Qualifications

Minimum 5 years in international Pharmaceutical and/or Medical Device industry with increased level of responsibility

Minimum 3 years of experience in QA technical role. Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements

Ability to operate efficiently in a complex matrix organization and international environment

Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels

Good knowledge of relevant computer packages e.g. Trackwise, SAP, Tracelink and documentation systems

• Excellent accuracy and attention to detail
  
• Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities
  
• The individual in this position is expected to represent the clients Pharmaceutical interests, objectives and policies in a responsible and professional manner
  

Education

Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)