Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen.
Post : External Manufacturing Qlty Manager API
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.
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.
• 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
Experience : 8-10 years
Qualification : M.Pharm, MSc
Location : Thane
Industry Type : Pharma
Functional Area : Pharmaceuticals
End Date : 30th May, 2021
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