JOB POSITION PURPOSE/ACCOUNTABILITIES

Provides leadership of the microbiology laboratory ensuring compliance with quality procedures and processes. Responsible for supervising laboratory personnel as well as performing test procedures in a laboratory environment to ensure quality. They generally consist of making measurements, performing various routine quantitative and qualitative analytical tests, performing calculations and determinations in the tests, and evaluating the physical-chemical characteristics. Analyzes the results of tests and experiments to ensure compliance with physical and/or chemical specifications.

RESPONSABILITIES:

• Manage the Microbiology/Quality laboratory team responsible for the product, microbiological tests, environmental monitoring of controlled manufacturing areas and bioburden programs (biological loads) for product families
• Ensures that team members are trained in laboratory methods
• Review laboratory documentation according to good documentation practices
• Lead validation projects for new instruments, methods, and equipment
• Provides support as required in plant projects (new equipment/modifications) to avoid environmental impacts
• In charge of the laboratory purchases by working closely with buyers
• Provides support as required by the EM programs of the N1, N2 and Magdalena plants
• Responsible for carrying out the Biodurden program of the product
• Responsible for complying with the Water Tests. Identifying sampling locations, creation of the sampling plan and data analysis
• Responsible for biocontamination assessments and control plans
• Responsible for the pest control program
• Supervises good laboratory practices, GPM's and GDP's
• Provides leadership during OOS lab investigations and follow-up on the implementation of corrective and preventive actions.
• Makes business-sense decisions, delivers results, and responds in a way that supports team and individual credibility.
• Administration of all quality operations for the A.L.P. process. including, but not limited to: quality inspections, process validation evaluation, environmental management and Good Manufacturing Practices, non-conformity management, CAPA, internal audits and exception reporting, external audit management and ensuring FDA compliance , ISO and other regulations of other countries.

• Prepares reports for management.

• Maintains all the documentation to ensure data accessibility and protection of information ownership.
• Continuously works to improve all the systems under his responsibility.
• Report dangers and injuries to the Leader and/or Immediate Supervisor.
• Comply with the safety and hygiene rules and environmental policy.
• Attend the trainings that are scheduled by the company.

Responsible for executing regulatory requirements according to the quality manual

REQUIRED CALIFICATIONS:

Education: University degree related to job description.

English: Intermedium

Experience: Minimum 4 years.

Preferred Qualifications: Biological / Microbiology / Biochemical