Quality Control Manager

buscojobs Brasil; Bahia; Presencial; BRL 20.000 - 80.000; Tempo integral

Resumo da oferta

A leading company in Brazil seeks a Quality Control Manager to plan and lead quality control operations and stability studies. The successful candidate will ensure compliance with regulatory guidelines, oversee a team, and contribute to timely product launches. A robust background in pharmaceutical quality control is essential for this role.

Qualificações

• Minimum 9 years experience in pharmaceutical quality control.
• At least 2-3 years in team leadership roles.
• Knowledge of cGMP and GLP principles.

Responsabilidades

• Plan and monitor quality control operations and stability studies.
• Ensure compliance with cGMP and GLP guidelines.
• Investigate batch non-conformances and propose CAPAs.
• Coordinate stability studies to meet launch schedules.

Conhecimentos

Leadership

Technical guidance

Regulatory compliance

Formação académica

9+ years in pharmaceutical quality control

Descrição da oferta de emprego

Job Purpose

Plan and lead the quality control routine operations and stability studies, driving the team to ensure testing complies with GLP guidelines and regulatory requirements. Aim for the timely release of batches and SRB targets to meet unit OTIF.

Key Accountabilities

1. Planning and Monitoring: Plan quality control operations and stability studies for timely completion and smooth release activities. Monitor commitment dates for RM, PM, FP, water analysis, and validation sections through performance dialogues and handshakes. Review plans and monitor execution across shifts to prevent delays. Ensure resource availability by reviewing monthly and production plans.
2. Execution and Compliance: Oversee routine quality control and stability studies to ensure timely delivery, regulatory compliance, and adherence to cGMP and GLP. Provide technical guidance in chromatography and experiment design. Implement specification updates and review reports to prevent data integrity issues. Manage sample charging, pull-out, storage, destruction, and monitor stability chambers.
3. Investigation and Issue Resolution: Investigate batch non-conformances, root causes of OOS/OOT, and stability chamber excursions. Propose CAPAs, ensure proper routing of non-conformances, and communicate with QC/QA heads to close CAPAs timely.
4. Stability Studies and Product Launch: Ensure stability studies are completed per schedule to avoid launch delays. Analyze stability samples accurately and verify testing schedules. Coordinate with R&D regarding product dossier filing and escalate issues as needed.
5. Team Development and Training: Provide technical guidance and evaluate team performance. Identify training needs based on guidelines updates. Monitor training on lab techniques, quality procedures, and cGMP & GLP principles. Review productivity metrics and ensure analyst qualification and training completion.

Skills & Knowledge

Educational qualifications: 9+ years in pharmaceutical quality control, with at least 2-3 years in team leadership.