Job Title: GxP Compliance Manager - Contract Manufacturers
Description:
We are seeking a highly skilled and experienced professional to ensure GxP compliance in the management of subcontracted manufacturers within the Almirall group's pharmaceutical products.
Key Responsibilities:
* Ensure implementation of KPIs for CM QMS
* Identify and propose improvement actions in CM QMS
* Review and maintenance of CM QMS SOPs
* Maintenance of QA agreements
* Follow-up of implementation of CAPAs from audits and inspections
* Participation in GMP audits
* Identify, propose and execute improvement actions in CMO performance
* Quality oversight of products
* Record and follow-up of quality events: change control, OOS, deviations and CAPAs
* Collection of PQRs from CMOs
* PQRs initial validation and submit for approval (eDMS)
* Product and MA compliance
* Follow-up of specific plans related to implementation of new regulations
Requirements:
* Bachelor Degree in Life science (Pharmacy, Chemistry, Biological sciences or similar subject)
* Good knowledge and skills in the use of advanced personal computer programs and systems such as Trackwise and eDMS
* Ability to influence and collaborate with others, negotiation and proactivity
* Advanced written and verbal communication skills in Spanish and English
* 2 / 3 years experience in GMP fabrication environment and contract manufacturers management
Core Values:
* Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed
* Courage: we challenge the status quo, we take full ownership and we learn from our success & failures
* Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets
* Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple