To develop, validate and transfer analytical test methods to support quality control testing of raw materials, packaging materials and injectable drug products formulations, ensuring delivery in accordance with project timescales and deadlines. To ensure the follow-up of analytical validation and transfer activities conducted locally.

To coordinate, review and evaluate analytical tests and results. To perform analytical investigations and analytical problem solving, in support of validation and analytical methods transfer and routine Quality Control activities.

To write and review protocols, specifications, method, monographs, reports and all the Quality systems documents related to Quality Control activities.

Specific Responsibilities

• Develop, validate and transfer analytical test methods for the testing of raw materials, packaging materials, injectable drug products and cleaning verification, according to Good Manufacturing Practices (cGMP) and ICH Q2 requirements.
• Implement new techniques, unify criteria and ways of working.
• Suppliers evaluation and equivalence of materials.
• Write / review protocols and reports for the development, validation, verification, equivalence and transfer of analytical methods.
• Write / review specifications, method, monographs and all the Quality systems documents related to Quality Control activities.
• Coordinate and review the activities performed by the analysts.
• Manage reference standards, reagents, and material of the laboratory.
• Train the analysts in new and reviewed procedures or tests.
• Conduct investigations and write analytical investigation reports.
• Solve analytical chemistry problems. Provide analytical support and expertise to the team.
• Investigate, complete and follow up OOS, Deviations and CAPAs assigned. 
• Collaborate with other departments (QA, Regulatory, R&D, Production and Procurement/ Purchasing) to develop analytical and clinical documentation for regulatory documents for new product development (drug substance, drug product, etc.) or deficiencies letters.
• Collaborate to and review analytical sections of CMC documentation for filing.
• Participate and contribute to project reviews.
• Ensure that new regulations and updated versions are applied.
• Communicate and present updates of the progress of the analytical work of each project.
• Supervise, motivate to the analysts.
• Ensure good relationships and collaboration with all other teams in QC, Operations, QA, Regulatory Affairs, etc.

• Requirements and personal skills

• Education: Degree in Pharmacy, chemistry or similar.
• Languages: Fluent English and Spanish.
• Experience (years/area): Minimum 2 years of experience in Pharmaceutical Laboratory or GMP environment, including experience in Gas and Liquid Chromatography.
• Specific Knowledge: Strong knowledge in analytical instrumentation. Solid expertise in chromatography, Empower is a must. Knowledge of GMP regulation, ICH, FDA, USP and Ph. Eur.
• Personal skills: Proactive, decision-making, and creative with good problem-solving skills. Ability to communicate and effectively interact with cross functional teams and outside teams.