ESO / Pharma CMOs |International managing position / Home based available
International API & FDF producer
Global QA Manager ESO
Ensure compliance quality standards and GxP standards.
QMS: procedures adaptation and implementation in electronic quality management system (eQMS)
Oversight and execution the audits of suppliers, tracking and performing the supplier's qualification.
Supporting audits by customers and Internal audits.
Oversight of CMOs and monitoring (performance log), giving input for Quality Management Review.
Supporting change control process awareness in the organization. Oversight of change controls related to CMOs.
Oversight and support of technology transfers : CMO qualification for API and FDF: audit, review of technical documentation, AMT and validation (if required), process validation protocol and analytical method protocol.
Oversight of stability studies and trending from quality perspective. Streamlining stability process.
PQR assessments and follow-ups with CMOs.
Leading, oversight and support of Deviations, OOS and investigations related to CMOs.
Oversight and support of quality agreements with CMOs.
Requalification of suppliers.
Responsible Person
Management GMP activities and records: focusing on the management of authorized activities and the accuracy and quality of records.
Training: ensuring that initial and continuous training programs are implemented and maintained.
Recall: coordinating and promptly performing any recall operations for medicinal products.
QMS: a quality management system is implemented and maintained.
Complaints: ensuring that relevant customer complaints are dealt with effectively.
Suppliers and customer qualification: ensuring that suppliers and customers are approved.
Outsourced activities: approving any subcontracted activities which may impact on GDP.
Self-inspection: ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
Oversight of records: keeping appropriate records of any delegated duties.
Returned, rejected or falsified products: deciding on the final disposition of returned, rejected, recalled, or falsified products.
Management of Returns: approving any returns to saleable stock.
Additional requirements applicable for the national law: ensuring that any additional requirements imposed on certain products by national law are adhered to.
SPAIN home based option.
Barcelona city office.
Great salary package.
Social Benefits.
International scope.
Requisitos mínimos
Master degree in Pharmacy, Chemistry, Biotechnology or other relevant study QC and analytical background.
7+ years of Quality Assurance experience in Pharmaceutical sites under GMPs guidelines.
Work in a multidisciplinary way with Contract Manufacturing Organizations (CMOs) functions ensuring proper development and implementation of key projects.
Periodically report the progress status of key strategic actions.
Supporting Quality ESO team.
Proactively offer a range of services that meet current and future projects.
Provide training and support to help project managers succeed in their projects.
Fluent in English.
Willing to travel internationally 20-30%.
Full of initiative, flexible, and capable of analyzing problems on.
Natural builder of relationships and express your ideas clearly, with ease and flair.
Able to operate effectively across multi-functional teams.
Ability to identify opportunities and gaps and put operational and strategic plans in place to realize opportunities or fill gaps.
