Analista de Desarrollo Analítico - Buenos Aires, Argentina - Pfizer

Pfizer

Empresa verificada

Buenos Aires, Argentina

hace 1 semana

Publicado por:

Sofía Rodríguez

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Descripción

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.

Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will train others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to our patients.

How You Will Achieve It

Design and execute experiments for the development and validation of analysis methods.
Execute familiarization and analytical transfer tests.
Execute the analysis of samples from process validations and those included in the plan of stabilities of Analytical Development.
Perform the analysis of the samples of validations and / or cleaning monitoring scheduled annually
Issue documentation protocols and analytical reports (development, validation, transfer, stability, etc.)
Generate the analytical documents required to submit to the Health Authority for the registration and approval of new products.
Properly collect and maintain samples for analysis.
Verify the analysis documentation generated in the sector.
Document all analyses performed in full compliance with GMP standards and other regulatory requirements.
Maintain proper order in the laboratory (housekeeping).
Properly use laboratory equipment.

Responsible for the maintenance in perfect condition of the equipment /s in charge.

Provide support during laboratory investigations
Followup and colsure of CAPAs on date.
Write and/or update the SOPs related to the activities of Analytical Development
Generate the specifications and analysis methodologies of the new products.
Update the specifications and analysis methods in force as a result of regulatory commitments, revalidations or other sources in which technical activity is required.
Develop the assigned secondary activities (standards, reagents, columns, etc.)
Get involved in the projects of the Plant.
Work in IMEx (Integrated Manufacture Excellence) environment.
Work in a dynamic context with diverse projects.

Qualifications:

Must-Have

Advanced student or graduate in Pharmacy, Chemistry, Biotech or similar career
English: Intermediate level
3+ years' experience in similar positions within Pharmaceutical Industry
Ability to write clear technical document.

Nice-to-Have

Bachelor's Degree
English: Advanced level
Previous experience in analytical method transfer and validation
Experience in biological products testing
Lean Six Sigma certification (green belt or superior)
Deep knowledge in GxP regulations
Good organizational and time management skills
Good oral and written communication skills
Good Microsoft Office skills
Effective problem solving skills

Work Location Assignment:
On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

LI-PFE