Job Description

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Validation Analyst x2

Purpose:

Execution of analytical method validation, cleaning validation, process validation, and stability studies for new formulations, within a pharmaceutical environment compliant with regulatory requirements (GMP, ICH, Pharmacopoeias, etc.).

Key Responsibilities:

Analytical Method Validation

• Draft validation protocols (ICH Q2), perform tests, calculate and interpret results.
• Prepare validation reports and ensure GMP compliance.
• Develop and optimize analytical methods.
• Execute method transfer protocols (internal/inter-site).
• Coordinate testing with partner labs and ensure documentation closure.

Process Validation

• Participate in the planning of process validation activities in collaboration with project managers.
• Draft process validation protocols in accordance with ICH guidelines.
• Support and collaborate with the production team during the launch of new formulations or during revalidation activities.
• Execute process validation QC testing
• Collect, analyze, and interpret process performance data
• Prepare process validation reports and ensure documentation compliance

Cleaning Validation

• Develop cleaning validation protocols in accordance with GMP requirements and international guidelines.
• Define acceptance criteria based on residue limits (MACO, PDE, toxicology, solubility, etc.).
• Participate in risk assessments to determine equipment, products, and processes requiring validation.
• Supervise or perform sampling activities (rinse sampling, swabbing).
• Analyze samples using appropriate analytical techniques.
• Prepare cleaning validation reports and ensure documentation compliance.
• Ensure periodic revalidation according to regulatory requirements and process changes.

Stability Studies for New Formulations

• Implement stability studies in accordance with ICH requirements.
• Draft stability protocols (conditions, sampling points, analytical parameters).
• Initiate stability batches (long-term, accelerated, intermediate).
• Perform analyses at each stability time point
• Compile and interpret analytical results.
• Communicate results to Development, Quality Assurance, and Regulatory Affairs teams.

Cross-Functional & Quality Responsibilities

• Ensure effective communication with QA, QC, Production, and Supply Chain to support smooth execution of validation activities.
• Participate in cross-functional meetings and ensure proper follow-up of assigned actions
• Lead investigations related to deviations, OOS, OOT, or analytical issues, and implement appropriate CAPA.
• Support investigations related to cleaning deviations or contamination events.
• Ensure timely follow-up of stability trends, deviations, and potential risks.

Technical Skills Required

• Proficiency in analytical techniques : HPLC, GC, UV/Vis, IR, dissolution, titrimetry, AAS, ICP, etc.
• Strong knowledge of regulatory standards: GMP, ICH Q2, ICH Q1, ICH Q8–Q11.
• Understanding of cleaning validation principles: MACO, PDE, toxicology, solubility, cross-contamination.
• Knowledge of Pharmacopoeias (European, USP) and their application to analytical methods.
• Ability to draft protocols, reports, SOPs, and quality documents in compliance with regulatory requirements.
• Ability to perform risk assessments and identify and evaluate critical points.
• Proficiency with chromatographic data systems (Empower).
• Understanding data integrity principles.
  
  

Qualification, Skills & Experience:

• Master’s degree (Bac+5) or higher in Chemistry, Analytical Chemistry, or any equivalent scientific field
• Mandatory experience in analytical validation within a pharmaceutical laboratory
• Desired experience in cleaning validation and process validation
• Between 5 and 12 years of experience in a pharmaceutical laboratory
• Proficient in French and possess a good level of the English language

Location:

Morocco : Casablanca-Settat : Casablanca / Aéoropole

Division:

Consumer Health

Reference Code:

865102

You can contact us here:
https://www.bayer.com/fr/ma/afrique-du-nord-contact