Chemistry Manufact. Control Specialist Ancona

Chemistry Manufact. Control Specialist
Ancona
Marche, Ancona

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