Job Description
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We are seeking a Quality Assurance Specialist to support our biologics compliance team. As a key member of the team, you will be responsible for ensuring that all quality management systems and processes are in place to guarantee the highest level of quality.
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Key Responsibilities:
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* Support the qualification of new material suppliers and GMP service providers
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* Participate in auditing of GMP suppliers and GMP service providers from time to time
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* Act as SAP Key User for material supplier data
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* Support the review and approval of GMP supplier and service provider changes, including coordinating change control activities with internal and external cross functional teams
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* Support the resolution of quality deviations and closure of CAPAs
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* Support the internal audit program, including managing the schedule, conducting the internal audit and maintenance and reporting of metrics relating to internal audits
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* Participate and follow-up on audits and/or inspections carried out at the site by Regulatory Authorities or Clients
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* Participate in initiatives and action plans for the development of QA and improvement of GMP compliance
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* Manage and provide support for the site electronic quality management system (EQMS)
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* Provide site metrics and KPIs as required for the Quality Management System (QMS)
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* Provide support for the Quality Management Review (QMR) as applicable
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Requirements
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To be successful in this role, you will need to have:
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* A Bachelor's degree in a technical discipline such as biochemistry, chemistry or engineering
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* Demonstrated knowledge of Quality Management Systems and continuous/process improvement tools
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* At least 3-5 years' experience in the biotechnology and/or pharmaceutical industry within a Quality role
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* Strong technical aptitude, including ability to read and comprehend technical documentation and execute procedures
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* Strong knowledge of cGxP requirements and regulations
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* Knowledge of troubleshooting and problem-solving skills, including formal root cause analysis such as Ishikawa diagrams and FMEA
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* Auditor qualification would be an advantage
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* Demonstrated organisation and collaboration skills with a teamwork mindset
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* Excellent communication skills, written and oral
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* Analytical with demonstrated problem-solving and root-cause analysis skills
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Benefits
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We offer a competitive salary and benefits package, including:
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* Bonus
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* Parking
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* Pension
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* VHI
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About Us
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We are a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing.
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We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.
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We are an equal opportunities employer and welcome applications from diverse candidates.
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The ideal candidate will be able to thrive in a dynamic and fast-paced environment and be willing to travel when required.
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We look forward to hearing from you!