QC Compliance & Process Specialist (Microbiology)

Sanofi Inc.; Birmingham; In loco; GBP 51.000 - 77.000; Tempo pieno

Vantaggi offerti da questo lavoro

Top-tier healthcare

14 weeks gender-neutral parental leave

Descrizione del lavoro

Sanofi in Ireland seeks a QC Business Process Specialist to drive compliance and continuous improvement within the QC Lab Team. You will manage SOPs, deviations, CAPA and GMP compliance, and support LIMS/digital systems to keep the Microbiology lab efficient and regulatory-aligned.

You'll collaborate with QA and operations, lead training on compliance topics, maintain documentation, identify risks, and help prevent recurrence through strong CAPA execution; a strong background in pharma

Competenze

• Experience ensuring compliance with pharma regulations and standards.
• Experience managing internal audits and regulatory inspections, including preparation and follow-up.
• Knowledge of FDA, EMA, ICH guidelines and GMP requirements.

Mansioni

• Contribute to development and maintenance of an effective compliance program.
• Ensure operations comply with regulatory requirements and standards.
• Provide training on compliance topics.
• Maintain compliance documentation for accuracy and completeness.
• Identify compliance risks and help develop mitigation strategies.
• Support investigation and reporting of compliance incidents.
• Manage CAPA to address incidents and prevent recurrence.

Conoscenze

Regulatory compliance

CAPA management

SOP/procedure management

Audit support

Strumenti

LIMS

Document management systems

Descrizione del lavoro

Sanofi in Ireland seeks a QC Business Process Specialist to drive compliance and continuous improvement within the QC Lab Team. You will manage SOPs, deviations, CAPA and GMP compliance, and support LIMS/digital systems to keep the Microbiology lab efficient and regulatory-aligned.

You'll collaborate with QA and operations, lead training on compliance topics, maintain documentation, identify risks, and help prevent recurrence through strong CAPA execution; a strong background in pharma