Bayer Hiring External Manufacturing Qlty Manager API Master Degree in Pharmacy/ Biology/ Chemistry/ Biotechnology Apply Now
POSITION PURPOSE:
The main purpose of the position is to manage quality
oversight of third-party contractors (e.g. manufacturers, service-providers,
etc.). Assures pharmaceutical product quality, regulatory and cGMP compliance
of PH PS products sourced from third-party contractors by setting, implementing
and verifying QA standards for the assigned API portfolio.
YOUR TASKS AND RESPONSIBILITIES:
• Responsible for QA management and QA oversight of processes and products of the assigned portfolio including quality and regulatory requirements, prioritization, problem solving and escalation to Sr. Management, while assuring/ monitoring the quality performance of third-party contractors by tracking respective quality KPI’s.
• Designated QA key contact to the assigned third-party contractors thus holds expert knowledge for processes and products of assigned portfolio.
• Interacts directly with third-party contractors and acts as quality interface towards other PS functions including utilization of respective Bayer quality systems to ensure GXP-compliant documentation of all Quality operations.
• Responsible for QAA management including negotiations and disputes
• Manages teams across functions to provide highly scientific evaluation of issues intended to mitigate quality and compliance risk while maintaining product supply
• Supports/manages Q-topics related to product launches/transfers with regards to quality requirements and their implementation.
• Maintains awareness of current GMP trends and manufacturing processes and supports continuous improvement of the product quality
• Assures regulatory and cGMP compliance with approved dossiers and provides support for regulatory agency inspections and requests
• Focus is internal and external. Interacts with team members, peers and Department Heads. May delegate operational tasks (whilst staying responsible) to Q-team members such as QA KPI monitoring, deviation evaluation, PQRs, etc.. Maintains an external network in field of expertise.
WHO YOU ARE:
• Master Degree in Pharmacy/ Biology/ Chemistry/ Biotechnology, PhD preferred..
• Minimum of 5 years of relevant experience in Quality Assurance in pharmaceutical manufacturing of API.
• Profound expertise in Quality Assurance in Pharmaceutical/Biotech required with advanced knowledge and experience in subject matter areas as Production (API) /QC/Chemical/ Regulatory
• Experience in oversight of contract manufacturing is preferred
• Broad cGMP experience and knowledge, QA/QC and regulatory compliance (US and other international agencies)
• Qualification or expertise in GMP/ISO Audits
• Stand for Bayer Quality standards towards CMO and shows courage in difficult situations
• Drive results and manage others to achieve corporate, site, and departmental objectives
• Must be able to make tough decisions under pressure
• Strong leadership
• Communication skills with a collaborative style
• Diligent, thorough and solution oriented
• Ability to interact and gain the support of senior management.
• Ability to effectively manage multiple, complex priorities.
• Proficiency in English
TO APPLY CLICK HERE
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