Description
Job Summary:
Laboratorios Richmond is seeking a proactive Process Validation Specialist to ensure compliance with the Validation Plan, execute and document processes, and participate in external audits.
Key Responsibilities:
1. Ensure compliance with the Process Validation Plan
2. Execute and document assigned process validations
3. Participate in external audits and departmental tasks
At Laboratorios Richmond, we are looking for a Process Validation Specialist to join our Validation and Qualification team. The role will be based at our Pilar Plant, and responsibilities include:
Ensuring compliance with the Process Validation Plan.
Executing and documenting assigned process validations.
Drafting Process Validation Protocols and Reports, preferably for oral solid dosage forms (not exclusive).
Drafting risk assessments.
Investigating root causes related to validation (e.g., 5 Whys, Ishikawa).
Monitoring the follow-up of Deviations, Change Requests, Non-Conformities, Anomaly Reports, and Corrective and Preventive Actions associated with the Process Validation Plan.
Participating in external audits at third-party manufacturing plants and suppliers in general.
Participating in general departmental tasks within the Validation and Qualification area.
We are a regional pharmaceutical company headquartered in Argentina, committed to excellence and continuous improvement: we develop and manufacture high-quality medicines with added human value.
We share the vision of a world where health is not a privilege. Therefore, we aim to contribute to improving, protecting, and safeguarding people's health.
We help people live longer and better!
Requirements
Minimum 3 years of experience in similar positions within the pharmaceutical industry
Autonomy and proactivity within the department
Extensive knowledge and application of regulatory requirements
**Proficiency in statistical tools:** CP, CPK, 3-sigma (Minitab preferred).
Desirable experience in certifications with national and international health authorities (e.g., INVIMA)
Technical English
Intermediate/Advanced proficiency in Microsoft Office
Rigorous data management
**Education:** Advanced student or graduate in Pharmacy, Biochemistry, Biotechnology, Chemistry, Chemical Engineering, Chemical Technician, or other university degree related to the pharmaceutical industry.
Benefits
Health coverage through a private health insurance plan for you and your family
Virtual discount voucher for access to the best offers across various categories
Meal benefit
21 consecutive vacation days from date of hire
Richmond Week: additional week of rest during the holiday period
Birthday leave
Transportation service to the Pilar Plant.