Quality Manager

  • Company:
    Boehringer Ingelheim
  • Location:
  • Salary:
    negotiable / month
  • Job type:
  • Posted:
    18 hours ago
  • Category:

Description: We are hiring a Quality Manager (3PQM) for Algeria based in Algiers who will be responsible for management and on-site quality oversight of all third party GMP manufacturing activities at Third Party Manufacturers (CMOs) and related products that are assigned to 3PQM META network in Algeria and in line with current GMPs and relevant regulatory requirements.Ensure that the quality management system is being followed and maintained in line with the BI pharmaceutical quality system (PQS) and regulatory expectations. Responsibilities: • Ensure that BI pharmaceutical quality system (PQS) of 3PQM META is followed by the internal organization, at the interface to the CMOs and at the CMOs throughout the contract life cycle, by ensuring the Quality Assurance Agreement (QAA) is being followed by CMOs. 1. Discrepancy Management: • Ensure that customer complaints and deviations related to the assigned products\CMOs are reported, recorded, investigated and closed in a timely manner according to the SOP and the approved QAA. • Ensure effective root cause analysis (RCA) is conducted and that Corrective and Preventative Actions (CAPA’s) are put in place and implemented effectively at the assigned CMOs. 2. Change Management • Ensure changes that can have an impact on BI products are managed compliantly according to the approved procedure(s) and QAA(s). • Act as overall Quality responsible person at the assigned CMOs and first point of escalation to resolve quality issues with CMOs and at BI/CMO interface. When necessary, escalate issues to the Head of 3PQM META to resolve conflicts promptly and minimize risk to Boehringer Ingelheim.• Supervise and oversee in person the execution of GMP activities (e.g. manufacturing, packaging) related to manufacture of BI products at the assigned CMOs to ensure that these activities are executed in compliance with GMP requirements, BI PQS and the approved QAA (e.g. GMP documentation practices, data integrity, following approved manufacturing instructions, failure management) with the purpose of minimising the risk to patients and BI products quality.• Ensure regulatory compliance and high quality standards of products manufactured at the assigned CMOs.• Maintain full product risk oversight and proactively drive risk reduction programs at the assigned CMOs.• Participate in the quality expert meetings, and CMO rating and Business Review Meetings.• Identify and communicate risks, propose and implement risk mitigation measures.• Contribute to the monthly Quality Management Review (QMR) meeting of 3PM\3PQM META. Present relevant Quality topics as required.• Follow up and oversee the implementation and timely reporting of the required data e.g. for Continuous process verification, BI products stability programme, trending and trend analysis according to the SOPs and the approved QAA.• Represent 3PQM META in technology transfer projects as required. Requirements: • 4-6 years of relevant Quality Assurance experience in the Pharmaceutical manufacturing environment with demonstrated ability to interpret and implement international pharmaceutical GMP requirements. Quality Control experience is highly desirable.• Demonstrated experience in managing and overseeing Quality in Third Party Manufacturing operations and contract manufacturers would be beneficial. • Good knowledge of GMP and Quality Systems with strong technical knowledge and hands on experience of GMP requirements associated with pharmaceutical production. With demonstrated ability to interpret and implement international pharmaceutical GMP requirements.• Demonstrated understanding and experience in discrepancy management (e.g. customer complaints, deviations, conducting investigation, root cause analysis and CAPA management and follow up.• Demonstrated understanding and experience in managing change controls.• Demonstrated experience in equipment qualification and process Validation. Competencies and Skills: • Possess a strong attention to details with record of driving quality performance in a commercial environment while maintaining a quality-focused attitude.• Demonstrates strong oral and written communication skills and interpersonal skills.• Must possess strong analytical and problem solving skills.• Demonstrated skills in the use of information management systems in a GxP environment (e.g. Trackwise, SAP) and good working knowledge of Microsoft office.• Ability to appropriately balance compliance and business needs to ensure problems are identified, clearly articulated and resolved with the right sensitivity to timing, risk consideration and overall business impact.• Results driven with demonstrated customer and quality focus• Ability to make decisions, evaluate risks& define and execute an action plan• Ability to propose innovative solutions to solve problems• Influencing and negotiation skills to achieve win-win situations• Strong organizational skills• Good command of English and French languages (Speaking, Reading and writing) knowledge of Arabic language is desirable. This position requires flexbility in working hours. Who we are: At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key, because your growth is our growth.

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