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Other
Job Reference:
54b490023387
Job Views:
4
Posted:
03.03.2025
Expiry Date:
17.04.2025
Job Description:
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 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.).
o Review of CMO batch documentation for Stragen or customer release.
o Review and approval of change requests.
o 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 acts 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 demonstrate independence, objectivity, and ethics
* Able to apply good judgement and good appreciation of quality issues
* Able to work under pressure
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
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