Associate Process Expert

Healthcare Businesswomen’s Association; Mazatlán; Presencial; MXN 480,000 - 600,000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical industry is looking for a dedicated Quality Assurance professional to manage deviations and implement corrective actions. This role is crucial for ensuring product compliance and entails overseeing investigations while working cross-functionally. The ideal candidate will have significant experience in the pharmaceutical sector, especially within GMP environments, and will play a key role in training and compliance.

Formación

• 2-5 years of work experience in the pharmaceutical industry, especially in QA or QC roles.
• Direct experience in GMP and aseptic environments is required.
• Investigator Certification is required.

Responsabilidades

• Manage deviations and investigations within established timelines.
• Implement CAPAs and ensure compliance with GMP systems.
• Develop training for Cell Processing team members.

Conocimientos

Change Control

Good Documentation Practice

Root Cause Analysis (RCA)

Lean Manufacturing

Manufacturing Process

Risk Management

Educación

Bachelor's degree in a relevant field

Advanced degree (desirable)

Descripción del empleo

Job Description Summary

This role will author and oversee deviations, investigations, CAPAs, and related reports to ensure closure within the established timelines for the manufacturing department.

Job Description

Deviation and Investigation Management:

• Open deviations and assess the criticality of the deviation within required timeframes
• Assess impact to any products involved in deviations, ensuring product impact is assessed in alignment with batch release activities
• Author investigations
• Owning investigations and developing corrective actions
• Use process knowledge and root cause investigation tools to identify root causes of product and process deviations.
• Ensures robustness (complete, accurate and defendable) of all critical and major investigations
• Author and execute any experiments or runs to support investigations
• Work cross-functionally to assess and analyze deviations and investigations to determine impact
• Work cross-functionally to ensure production continues in a compliant manner in the event of a deviation and document accordingly.

Corrective and Preventive Actions:

• Generation and documentation of effective corrective and preventative actions
• Ensures all CAPAs are implemented through GMP systems (e.g. MBR revision, training, etc.)
• Monitor and ensure effectiveness checks of CAPAs are conducted
• Communicate to the production team any training or awareness events to reinforce quality behaviors.

MES Order Management:

• Generation of manufacturing orders within the MES system, as required.

Training:

• Develop training (as immediate response to unexpected events, for technical document execution, and new products/processes) to the Cell Processing team, as required.
• Maintain compliance with training requirements.

Key Performance Indicators:

• Quality measures (e.g., deviations, oos rate)
• Schedule adherence to operational model
• Opening and closing investigations within time frame
• Production right first time
• Costs and budget (e.g. overtime)

Ideal Background:

Education: Bachelor's degree with 2-5 years of work experience in the pharmaceutical industry or equivalent. An advanced degree is desirable.

Languages: Fluent in speaking / writing in English

Experience:

• 2-5 years of related pharmaceutical experience preferably in a production, QA, and/ or QC related role preferred. Direct experience working in a GMP and aseptic or sterile environment is required. Cell & gene therapy experience highly desired.
• Investigator Certified required

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Experience with 1QEM

Skills Desired

Change Control, Chemical Engineering, Continual Improvement Process, Efficiency, Employment Discrimination, Flexibility, General Hse Knowledge, Good Documentation Practice, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Physics, Process Control, Production Line, Productivity, Risk Management, Root Cause Analysis (RCA), Scheduler, Technology Transfer, Well-Being