- Key Responsibilities· Contribute to CSV strategies, plans, and protocols in accordance with regulatory As a QA IT CSV Engineer, you will be responsible for ensuring compliance for computerized systems and computerized systems validation, fulfill with regulatory requirements and operate as intended.Your primary responsibilities will include:guidelines (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5)· Contribute to risk assessments and participate to test scrKey Responsibilities· Contribute to CSV strategies, plans, and protocols in accordance with regulatory As a QA IT CSV Engineer, you will be responsible for ensuring compliance for computerized systems and computerized systems validation, fulfill with regulatory requirements and operate as intended.Your primary responsibilities will include:guidelines (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5)· Contribute to risk assessments and participate to test scr
- The MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements.To evolve in this environment, we are looking for our next Process Validation Expert to ensure theThe MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements.To evolve in this environment, we are looking for our next Process Validation Expert to ensure the
- Pour Merck à Aubonne, nous recherchons notre prochain/e QA DS Operations Expert, pour une durée de 6 mois. En tant que QA DS Operations Expert, vous interviendrez pour le support sur le process de déviations / investigations Stand-alone et CAPA pour le département Biotech.Votre rôle : Supporter les ouvertures de déviations, les évaluations d'impact et les clôtures de celles-ciSupporter les assignés dans les investigations, la définition des actions à mettrPour Merck à Aubonne, nous recherchons notre prochain/e QA DS Operations Expert, pour une durée de 6 mois. En tant que QA DS Operations Expert, vous interviendrez pour le support sur le process de déviations / investigations Stand-alone et CAPA pour le département Biotech.Votre rôle : Supporter les ouvertures de déviations, les évaluations d'impact et les clôtures de celles-ciSupporter les assignés dans les investigations, la définition des actions à mettr
- The MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements.To evolve in this environment, we are looking for our next Process Validation Expert. You will be rThe MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements.To evolve in this environment, we are looking for our next Process Validation Expert. You will be r
