CHANGE CONTROL SPECIALIST

FILIALE: FROSINONESPECIALIZZAZIONE: CORE SKILL - Life Science

Grafton LifeScience* is a dedicated team focused on enhancing the experiences, skills, and potential of candidates in Sales & Marketing, Clinical Research, Regulatory, and Operations within the Pharmaceutical and Medical sectors. We also specialize in roles related to customer support in the health-impacting distribution field (Pharmacies and Parapharmacies).We are a team of passionate professionals working to guide our candidates towards roles and corporate environments that best match their skills and expectations.

 

In partnership with an integrated CDMO with around 60 locations worldwide, specializing in integrated sterile liquid and lyophilized product development and commercial manufacturing, we offer an opportunity for

 

Change Control Specialist

The main function of a Change Control Specialist is to ensure the effective management of the change control process within the Quality System, supporting readiness for manufacturing and batch release. This role ensures compliance with company procedures and regulatory standards, enabling timely production and release of pharmaceutical products.

 

Main Responsibilities:

Supervise the change control process with specific focus on production and batch release

Follow the change control opening phase by verifying the proposed change and ensuring completeness of information and documentation

Lead preliminary assessments of change proposals and identify potential impacts to guide the evaluation process

Support the approval phase by verifying the presence and consistency of assessments and action plans for implementation

Collaborate with relevant departments to ensure effective communication with customers and external agencies

Participate in periodic meetings with customers, customer audits, and regulatory inspections

 

Required Skills: 1 2 years of experience in a Quality Assurance function within a pharmaceutical company.

Preferred Skills:

• Ability to work well independently and in a team environment
• Excellent interpersonal, communication, and organizational skills.
• Strong accuracy and attention to detail
• Experience with Microsoft Word and Excel.
• Familiarity with Good Manufacturing Practices (GMP).
• Proficiency with the English language. Degree/Certifications:
• Degree in Chemistry and Pharmaceutical Technologies (CTF), Chemical/Biological Sciences, or a related field.

 

Contract Offer: Fixed-term agency contract 6 months with the possibility of renewal. CCNL Chimico-Farmaceutico, livello D1.

Place of work : Ferentino (FR)

  Grafton LifeScience is a specialization of Gi Group Spa authorized to operate by the Ministry of Labor and Social Policies (Authorization No. 26/11/2004 PROT. 1101 - SG).

The offer is intended for candidates in compliance with Legislative Decree No. 198/2006 and subsequent amendments, as well as Legislative Decrees No. 215 and No. 216 of 2003 on equal treatment.

Candidates are invited to read the privacy notice pursuant to Articles 13 and 14 of EU Regulation 679/2016 at the following address: "

by helplavoro.it