Quality Assurance Specialist 100%

The QA Specialist is responsible for the quality oversight for the API / IP supply and manufacturing of products for the customers under his responsibilities.

Accountabilities

• Ensure qualification of corporate suppliers and subcontractors (API / IP suppliers, Contract Manufacturers, service providers, etc.)
• Performance of audits
• Establishment of Quality and technical agreements (writing and implementation)
• Execute of quality risk assessment process in a timely manner
• Ensure adherence of suppliers and contract manufacturers to corporate policies / procedures, regulatory MAs, applicable Quality and Technical agreements and applicable US and EU regulations such as those of Pharmaceuticals, Food Supplements and medical devices.
• Provide quality oversight of day to day operations performed at API / IP suppliers and Contract Manufacturers organization (CMO).
• Review and approval of GMP documentation (CMO Master Batch Records, CMO process validation protocols and reports, CMO stability studies protocols and reports, etc.).
• Review of CMO batch documentation for Stragen or customer release.
• Review and approval of change requests.
• Review and approval of PQRs.
• Management of deviations : Perform and document investigations according to internal procedures
• Management of complaints : Perform and document investigations according to internal procedures
• Management of CAPA : Establish and implement corrective and preventive actions according to internal procedures
• Management of product changeover : Perform, document and coordinate the implementation of change controls
• Management of Quality Risk Assessment : evaluate, control, communicate and review the risk according to internal procedures
• Execute alert and batch recall process
• Provide status reports, including relevant metrics, to HOD QA Operations; actively contributing to QA Operations department and Stragen goals and objectives
• Represents and act as QA Operational in the Product Launch team
• Represent Stragen Quality Assurance including face to face visits, internal / external audits, and Quality Review Meetings
• Support Quality Operations in internal / external audits and regulatory inspections.
• Provide support to customers for QA Operations topics
• Manage own time to carry out assigned duties that support business goals.
• Works as a resource to identify process issues and execute implementation of CAPA in a timely manner to ensure customer commitments are met
• Perform all other duties assigned by the Head of Department / the management

Personal core competencies

• Creativity in problem solving skills
• Good negotiation skills with customer-oriented attitude
• Excellent organizational skills
• Able to prioritize, assess urgency and set deadlines
• Able to manage multiple tasks simultaneously
• Able to establish collaborative relationships
• Able to demonstrate independence, objectivity and ethics
• Able to apply good judgement and good appreciation of quality issues
• Able to work under pressure
• Attentive to details

Skills

• Fluent in English, both written and spoken
• Knowledge of quality management standards / regulations
• Scientific background
• Solid knowledge of GMP and GDP

Qualifications / Prerequisites

• Scientific university degree
• At least 5 years of experience in a Quality Assurance department of a pharmaceutical company
• Experience working in close collaboration with customers & subcontractors
Il y a plus de 30 jours