Batch Record Review Coordinator

1 giorno fa

Firenze, Italia Menarini Group A tempo pieno

Overview:
The function is involved in the operational and document management of the Batch Record

Review sector within the Quality Assurance Department. There may also be involvement in corporate projects.

Functionally and hierarchically, the Resource will report to the Quality Assurance Manager.

Main Activities & Responsibilities:
The role involves the following activities:

- Coordinating the team responsible for Batch Record review.
- Supporting investigations into non-conformities, particularly in cases of Deviations.
- Managing both hard copy and digital analytical documentation (e.g., Certificates of Analysis).
- Liaising with laboratories responsible for analysis and all other stakeholders involved in the release process (e.g., Supply chain).
- Drafting documentation related to the company’s Quality System.
- Collaborating on the monitoring of CAPAs and KPIs, and on continuous improvement activities.
- Assisting with self-inspections and national and international inspections.
- Collaborating on activities with a direct impact on BRR (e.g., Deviations, Change control, Process Validation).
- Reviewing Master Batch Records.

Job Requirements:

- Degree in technical/scientific disciplines (preferably Pharmaceutical Chemistry and

Technology(CTF) or Pharmacy, Biotechnology, Chemistry).
- Good knowledge of spoken and written English.
- Experience in pharmaceutical manufacturing of sterile products (at least 5 years).
- Experience in team coordination, preferably for BRR activities.
- Leadership skills.
- Good interpersonal skills and flexibility.
- Willingness to travel.
- Strong awareness of quality KPIs and continuous improvement issues.
- Planning skills.
- Proficiency in software for spreadsheet and statistical analysis.
- Problem-solving abilities.
- Strong focus on working toward objectives and a lean approach.
- Knowledge of LIMS systems.

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