Descripción del empleo

* FDF & APIs / Pharma CMOs |International position / Home based available


International API & FDF producer

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


RP Back Up

* 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.
* Strong project management abilities.