We are looking for a Quality Assurance Manager. He/ She will develop following responsibilities:
* QA system activities, for SOPs maintenance and updates, based on current procedures in place in the company.
* Management of suppliers. Coordination and Implementation of supplier evaluations.
* Organization and implementation of Internal audits.
* Proposal and management of corrective actions with focus on continuous improvement.
* Management of validations (transport, software) including Validation Master Plan performance.
* Keep updated on GMP regulations and evaluate the impact within our own Quality System and activities.
* Lead, manage and ensure proper GMP/GDP training throughout the company.
* Ensure that GMP requirements and quality standards are recognized, understood and maintained across the Company.
Previous experience required:
* Excellent level of knowledge of EudraLex Volume 4-cGMPs Guidelines, including cGDPs, GLP and FDA Guidelines.
* Experience in implementing Quality Systems in a GMP environment and direct experience with Health Authority Inspections.
* Experience in MS Office.
* Experience in SAP.
* Experience in TrackWise or similar platform.
Education:
* Degree in Pharmacy (mandatory for QP/RP responsibilities) or life sciences
* Master’s degree in Pharmaceutical Industry or related.
* Excellent level of English and Spanish, spoken and written.
* Auditor training and experience
Skills:
* Motivated, disciplined, proactive, dynamic, methodical, organized and decisive.
* Self-sufficient, influencing, leadership and management skills.
* Strong analytical and critical skills to troubleshoot complex problems.
* Highly responsible and capable to work under pressure to meet deadlines.
* Ability to prioritize multiple tasks.
* Good team player and collaborative working style with the ability to build partnerships with key stakeholders.
* Excellent organizational, planning and time management skills, to achieve project timelines.
* Detail oriented professional with strong written and oral communication skills.
* Report redaction (risk assessment evaluation report, audit report, among others).