Overview: Manage the Physical Chemical Quality Control Laboratory to contribute to the overall Quality Control and site objectives.
Supervise activities for analysing of intermediate product, finished product, raw material, and packaging material (primary and secondary).
Supervise sampling of raw material and packaging material (primary and secondary).
Release of raw material and packaging material.
Responsibilities: Supervise activities: manage and organize the activities in the laboratory to analyse intermediate product, finished product, raw material, and packaging material.
Organize activities for sampling of raw material and packaging material, sterile and non-sterile.
Supervise the operation of equipment, processes and personnel.
Identify, troubleshoot and resolve problems in scheduling to maintain efficient operations.
Manage the investigation of OOS/OOTs.
Prepare activity and progress reports so that recurring problems, whether with product quality or reliability of test procedures, are identified and addressed.
Plan activities in accordance with priorities to ensure the release of materials and finished products on time.
Coordinate actions arising from deficiencies found in audits, CAPAS, change controls so that they can be carried out in the required timeframe.
Collaborate in qualification of equipment and validation of informatic systems.
Periodically evaluate the quality of the results obtained in the laboratory and recorded in SAP, trends, off-trend percentage to detect in time possible systematic errors or deviations.
Quality Assurance: ensure compliance with internal, external and regulatory quality standards, procedures and methods.
Resources management: Efficiently manage resources, equipment, consumables, reagents, ensuring optimal performance.
Make quotations and optimize costs.
Prioritize and assign tasks to ensure that team resources and activities are effective and that the activities timeframe and objectives are met.
Documentation: Review documentation related to laboratory activities and other documents to meet Quality System requirements.
Write/review specifications, procedures, monographs and analytical methods.
Desarrollo: ensure and foster professional growth and skills development within the team.
Manage the training of the team.
Supervise, coach and mentor team members.
Interdepartmental collaboration: working directly with other departments to solve problems and implement improvements.
Qualifications: Education: Degree in Pharmacy, Chemistry or similar.
Languages: Fluent English and Spanish.
Experience: Minimum 5 years of experience in Pharmaceutical Laboratory, GMP environment, managing technicians and analysts.
Specific Knowledge: Strong knowledge of GMP regulation, ICH, FDA, USP and Ph.
Eur.
Solid expertise in manage a GMP Quality Control laboratory.
Solid knowledge and experience in analytical techniques and Empower.
Personal skills: Proactive, decision-making, and creative with good problem-solving skills.
Ability to communicate and effectively interact with cross-functional teams and clients.
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