CORPORATE COLD CHAIN QA AND TECH TRANSFER SPECIALIST

Actual Talent is the talent acquisition consultancy that offers Executive Search RPO and Talent Solutions.

Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people diversity and inclusion innovation and cutting-edge technology.

Your mission:

This role will act as an expert in quality control and manufacturing for assigned molecules and finished dosage forms (FDFs). This includes managing changes in manufacturing and testing resolving incidents adding new API sources and overseeing any changes that could impact manufacturing processes with external CMOs.

Your major accountabilities:

• Define a quality control transfer strategy for the defined projects.
• Define a manufacturing and quality control transfer strategy for the defined projects.
• Define a lifecycle strategy for the assigned molecules and FDFs.

Your specific accountabilities:

• Assessment of analytical instruction for raw materials excipients and finished products.
• Definition of analytical method transfer strategy for the defined TT projects.
• Review and approval of analytical protocols and reports.
• Evaluation of proposed manufacturing process steps.
• Management and review of the documentation provided by Receiving unit CMOs in reference to the Manufacturing process (Master batch record & Process validation report). Collect the Master Batch records from Sending unit CMOs and to review and file into QMS system.
• Write review and approve technical documents: master batch manufacturing records analytical methods material lists specifications environmental conditions stability studies SOPs Quality Agreements etc.
• Write execute or review qualifications (equipment utilities facilities suppliers providers etc.) and validations (e.g. process cleaning transport etc.).
• Design transport routes validation protocols evaluate temperature excursions and define improvement actions for a stable supply chain.
• Participate in the assigned projects.

We would like you to have:

• University degree in Life Sciences or Engineering (Pharmacy Chemistry or Biology preferred). Master in Pharmaceutical Industry is a plus.
• Minimum of 2 years experience in analytical quality control of cold chain products in a Quality role within a pharmaceutical company.
• Proficiency in GMP Quality Management Systems (deviations complaints audits).
• Expert in IT tools: MS Office SAP LIMS.
• Analytical thinking problem solving initiative results orientation attention to detail.
• Languages: English and Spanish.
• Availability to travel: 15%