This role is a 12-month contract with a view to extension.
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 of the Operations, Engineering, and CQV functions together with major stakeholders such as Artwork, NPI, Supply Chain, External Quality, QC, IT, and QPs to ensure the reliable delivery of quality, safe, effective product to patients.
• Provide QA support for Risk-Based Verification (RBV) and Computer Systems Validation (CSV) activities in the capacity of a Quality Assurance Subject Matter Expert.
• Review and approve equipment/utility 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 the 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 packaging activities.
• Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, and responses to inspection observations, to monitor progress of follow-up actions.
• Provide Quality input, oversight, and guidance to deviations and investigations to ensure robust root cause analysis/CAPA definition and timely closure as per the company’s 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 the complaints process
• Define and report standard quality KPIs with recommendations for actions for improvement of College park operations.
• Supporting ‘right first time’ and continuous improvement from a systematic and compliance perspective.
• Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
• Minimum 5 years in international Pharmaceutical and/or Medical Device industry with an increased level of responsibility
• Minimum 3 years of experience in a QA technical role. Sound awareness and understanding of the ding of the pharmaceutical business, special regard for 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 companies Pharmaceutical’s interests, objectives, and policies in a responsible and professional manner.
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