Chemistry Manufact. Control Specialist

2 settimane fa

Ancona, Italia Angelini Pharma A tempo pieno

Requisition ID: 6015- Location: Ancona, IT- Company: ANGELINI PHARMA SPA- Professional area: Engineering, Production, Quality- Job Description:

- We have an opportunity for a **Chemistry Manufacturing Control Specialist** for our **Product Quality **Compliance** team located in **Ancona**.

**Job purpose**:

- Accountable for Management of Quality Dossier for medicinal product at time of submission and during Lifecycle ensuring compliance with Angelini global/local procedures and with national and international law/regulations for Angelini products
- Ensure interaction and alignment with the Competent QA, Local/ Global RA team, R&D, manufacturing sites, to support relevant priorities and objectives

**Major activities**:
Drafting of Common Technical Document - Module 3 Quality including management of 3.2.S Drug Substance, based on Drug Master File and/ or Certificate of Suitability, Module 2.3, 1.4.1 and any other applicable declaration/ documentation necessary for submission) for Marketing Authorisation Application/ Quality Variations
Lifecycle Management of MAs: change impact assessment and quality variations
Management of Competent Authority queries (Deficiency letters)
Participation to project teams with management of design control during product de-velopment
- Requirements:_
- Degree in a Pharmaceutical Chemistry & Technology or Pharmacy
- 1 year of experience in Pharma CMC (or alternatively in QA and/or RA and/or R&D)
- Good understanding of product development and approval processes to get new launches and LCM
- Innovative and critical thinking with performance-oriented drive
- Excellent interpersonal, communication and presentation skills
- Proficient in Microsoft Office (Word, Excel, etc), nice to have Track Wise Digital tools, etc.
- Fluent in English

Workplace**:Ancona

  • Quality Control Scientist

    1 settimana fa

    Ancona, Italia PHARMAPROGRESS A tempo pieno

    We are hiring a Quality Control Scientist. The Quality Control Scientist will be responsible for the followig duties: - The design, supervision and execution of the quality control studies - The management of the assigned projects keeping the deadlines and establishing a direct contact with the client - Technical document writing associated with the...

  • Open Positions

    1 settimana fa

    Ancona, Italia Kymos Group A tempo pieno

    Overview Location: Ancona (Italy) Contract: Temporary Working day: Full time Sector: Pharmaceutical and biopharmaceutical Vacancies: 1 Discipline: Quality Work modality: On site Kymos Group – Pharmaprogress is a reliable Contract Research Organization part of the Kymos Group, a fast growing company with a strong commitment to quality and a dedication to...

  • Open Positions

    3 giorni fa

    Ancona, Italia Altro A tempo pieno

    Overview Location: Ancona (Italy) Contract: Temporary Working day: Full time Sector: Pharmaceutical and biopharmaceutical Vacancies: 1 Discipline: Quality Work modality: On site Kymos Group – Pharmaprogress is a reliable Contract Research Organization part of the Kymos Group, a fast growing company with a strong commitment to quality and a...

  • Open Positions

    2 giorni fa

    Ancona, Italia Kymos Group A tempo pieno

    OverviewLocation: Ancona (Italy) Contract: Temporary Working day: Full time Sector: Pharmaceutical and biopharmaceutical Vacancies: 1 Discipline: Quality Work modality: On siteKymos Group – Pharmaprogress is a reliable Contract Research Organization part of the Kymos Group, a fast growing company with a strong commitment to quality and a dedication to...

  • Open Positions

    6 ore fa

    Ancona, Italia Kymos Group A tempo pieno

    Overview Location: Ancona (Italy) Contract: Temporary Working day: Full time Sector: Pharmaceutical and biopharmaceutical Vacancies: 1 Discipline: Quality Work modality: On site Kymos Group – Pharmaprogress is a reliable Contract Research Organization part of the Kymos Group, a fast growing company with a strong commitment to quality and a dedication to...

  • Open Positions

    1 settimana fa

    Ancona, Italia Altro A tempo pieno

    OverviewLocation: Ancona (Italy)Contract: TemporaryWorking day: Full timeSector: Pharmaceutical and biopharmaceuticalVacancies: 1Discipline: QualityWork modality: On siteKymos Group – Pharmaprogress is a reliable Contract Research Organization part of the Kymos Group, a fast growing company with a strong commitment to quality and a dedication to...

  • Open Positions

    2 giorni fa

    Ancona, Italia Kymos Group A tempo pieno

    OverviewLocation: Ancona (Italy)Contract: TemporaryWorking day: Full timeSector: Pharmaceutical and biopharmaceuticalVacancies: 1Discipline: QualityWork modality: On siteKymos Group – Pharmaprogress is a reliable Contract Research Organization part of the Kymos Group, a fast growing company with a strong commitment to quality and a dedication to...

  • Funzionario commerciale_Account Manager_Ancona

    6 giorni fa

    Ancona, Marche, Italia ANTICIMEX ITALIA - The Modern Pest Control Company A tempo pieno

    Anticimex s.r.l., azienda multinazionale leader nel settore dei servizi di disinfestazione, derattizzazione e sanificazione, ricerca un/a:Account manager - Funzionario commerciale - Sales Account / Anconaal/alla quale verrà affidato un portafoglio clienti consolidato con il compito di gestire le relazioni con i clienti esistenti e sviluppare il portafoglio,...

  • Field Service Engineer

    5 giorni fa

    Ancona, Italia Mase Consulting Ltd A tempo pieno

    Field Service Engineer / Pharmaceutical Automation TechnicianDo you enjoy the practical hands-on elements of engineering and have the desire to work on industry-leading, highly complex pharmaceutical equipment? Ready for your calling? This specialist equipment manufacturer is searching for a well-rounded Service Engineer / Service Technician to join their...