QC Manager Brazil

UCB S.A.; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A global biopharmaceutical company in São Paulo is seeking a Quality Control Manager to oversee the Quality Management System of the lab and ensure compliance with regulations. The ideal candidate must have a Bachelor's degree in Pharmacy, active CRF, and experience in quality control within the pharmaceutical industry. Fluent English is required. Join us in making a difference for people living with severe diseases.

Qualificações

• Valid active CRF is mandatory.
• Experience in quality control within the pharmaceutical sector is required.
• Fluent in English.

Responsabilidades

• Oversee the Quality Management System in the QC lab.
• Ensure timely completion of Quality deliverables.
• Manage audits and inspections.
• Coordinate with local and global stakeholders for quality risk management.

Conhecimentos

Quality Control expertise

Pharmaceutical industry knowledge

Team leadership

Regulatory compliance

Fluent English

Formação académica

Bachelor's Degree in Pharmacy

Descrição da oferta de emprego

At UCB, we put our heart, soul, and skills into making a difference for people living with severe diseases. Working together to push boundaries, we combine the best of our talents to unlock innovation. Will you join us on our pioneering journey?

To strengthen our team, we are looking to fill the position of Quality Control Manager.

Quality Control Manager is responsible to:

• Ensure oversight and execution of the local Quality Management System in QC laboratory.
• Ensure all applicable Quality deliverables are effectively monitored, managed and completed in a timely manner in accordance with Global and Local SOPs.
• Address any deficiencies identified through audits and inspections by providing guidance for identification and timely implementation of appropriate corrective and preventive actions.
• Maintain, and approve Specifications, Analytical Methods and QC procedures and other documents applicable to QC activities, as required.
• Provide support to execute internal self-inspection and audit programs when required.
• Ensure readiness and participation for all applicable GMP internal and regulatory inspections of QC laboratory.
• Quality oversight to Local GMP Vendors (e.g. CLOs, Lab consumables suppliers, equipment calibration and/or qualification service providers) used for QC activities in compliance with UCB procedures and applicable local requirements, including qualification, quality agreements, monitoring through audit and/or periodic assessment, and discontinuation.
• When required, collaborate with key GxP and business stakeholders to identify and assess quality risks, and support the local risk champion in risk mitigation activities. Together with site management and Quality Lead Brazil provide direction, formulate strategies and make decisions which ensure efficient Quality operations and Quality risk mitigation.
• Review the analysis records, confirm that all necessary tests have been performed in accordance with the product registration, and approve or reject the product based on the specifications.
• When a suspected OOS result is obtained, ensure that laboratory investigations are conducted and documented in compliance with applicable UCB procedures and local requirements in a timely manner. Determine the impact on other batches when laboratory error is identified as the most probable root cause. Drive a QC decision on the disposition of the product.
• Participate in the analytical method transfer project by providing expertise, reviewing and approving transfer documentation as necessary, and ensuring all applicable local requirements are met before initiating the transfer.
• Ensure that within the QC laboratory, a local training program is established, documented, is compliant with training management KPI targets, and its effectiveness is periodically checked, and when applicable continuous learning for the purpose of career growth, qualification, or regulatory requirement is implemented.
• Define and document roles and responsibilities and delegated GMP activities where applicable (e.g., job descriptions, quality agreements, QC procedures).
• Ensure information and documentation is maintained following applicable procedures and is stored in the appropriate UCB tool/system, and that appropriate local archiving system is in place.
• Communicate relevant quality matters within the relevant Affiliate organization, and with UCB stakeholders, including but not limited to quality issue escalation and regulatory intelligence, via the Regulatory Intelligence Network (RIN).
• Ensure compliance with applicable GMP/GDP UCB Business Continuity plans.
• Provide subject matter expertise and represent department interests in meetings, projects, committees, and improvement initiatives, as requested.
• Ensure compliance with applicable data integrity standards and procedures.
  

Technical Responsible

• Act as the Technical Responsible, and Responsible Person for Controlled Substances/Narcotics for UCB Brazil and CRF, in accordance with current GMP/BPD guidelines, Ordinance 344/98 and UCB procedures.
• First line for Health Authorities exchanges for GMP (audits, communications, etc.) for the Jaguaré site.
• Tasks include but are not limited to:
• ensure that the operations do not compromise the quality of medicines
• ensure that an effective quality system is implemented and maintained
• ensure that adequate records are maintained
• ensure that all personnel are trained to carry out their respective duties
• ensure that appropriate standards of GMP are maintained
• perform a monthly reagent stock count to notify the responsible agencies
• perform a monthly analytical standards stock count to notify the responsible agencies
• ensuring that any additional requirements imposed on certain products by national law are adhered to
• This position is granted all necessary powers by the General Manager of Brazil which are necessary to fulfil the legal requirements of the duties and responsibilities as Technical Responsible, and Technical Responsible for Controlled Substances/Narcotics of UCB Brazil and CRF according to local regulations and legislation.

Requirements:

• Bachelor’s Degree in pharmacy.
  
  
• Active CRF is mandatory.
  
  
• Quality Control experience within regulated pharmaceutical environment. Consumer Healthcare or Pharma industry required.
  
  
• Fluent English;
  
  
• Pharmaceutical industry experience is mandatory.

UCB and its subsidiaries promote diversity and inclusion in the workplace; we are an Equal Opportunity Employer.