GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders.
Post : GMP - Audit Manager
The primary purpose of the GMP Audit Manager is to perform and manage GMP compliance audits of Biopharm and Pharmaceutical facilities supplying highly regulated markets. In this role, you will provide additional Biopharm subject matter expertise within the GSK Pharma Supply Chain Asia auditing team. You will be responsible for evaluating the level of compliance of Pharma Supply Chain Internal and External facilities including R&D, manufacturing operations, Local Operating Companies (LOCs) and Local Service Providers with Good Manufacturing Practice, applicable facility policies and procedures and regulatory and contractual commitments. Your excellent communication and influencing skills will be a key deliverable for success in the role.
• Preparation of clear concise and objective audit reports of the highest level of quality that ensure that senior management is appraised of identified risks and that appropriate corrective action plans are implemented.
• Manage the interface with auditees and stakeholders (the latter may include Site Directors, Site Quality Directors, Heads of Support Functions).
• Promote early visibility of regulatory / compliance issues.
• Expand knowledge base through proactive knowledge sharing and collaboration.
• Achieving excellence in subject matter expertise to enhance the quality of audits provided.
• Develop self and others through giving and receiving feedback to promote excellence and continuous improvement.
• Provide input to Global QMS Documents and functional processes.
• Manage the interface with auditees and stakeholders (the latter may include Supply Chain Directors, Site Directors, Site Quality Directors, Heads of Support Functions, Research & Development Quality)
Typical work output will involve:
• Entity audits of Pharma Supply Chain GSK sites, LOCs and external manufacturing sites, including R&D, that are supplying and supporting India and other Asia markets, including highly regulated markets.
• Preparation of clear concise and objective audit reports of the highest level of quality that ensure that senior management is appraised of the identified risks and that appropriate corrective action plans are implemented.
• For-Cause audits based on regulatory actions or identified risk.
• Progress audits against risk mitigation plans or regulatory citation commitments.
• Bachelor of Science degree in a Scientific and/or Engineering discipline.
• Demonstrable Biopharm subject matter expertise (or a technically similar discipline). For example, 10 years experience in the pharmaceutical industry including 5 years experience specifically in Biopharm / Steriles / Aseptic related industries.
• Experience with /good knowledge of world-wide cGMPs, regulatory requirements, standards and Quality Management Systems for pharmaceuticals, APIs, and biopharmaceuticals.
• Experience identifying and/or managing quality compliance issues.
• Broad based understanding of Primary and Secondary Pharmaceutical manufacturing.
• Previous auditing experience (at least 3 years) preferred (e.g. Proficiency & experience in planning, performing & reporting Quality or Regulatory Compliance audits).
• A working knowledge and competency in evaluation of ALCOA+ principles within the Pharmaceutical industry.
• Excellent written, verbal, questioning, and listening skills.
• Auditor accreditation/certified either through the GSK internal Auditor Certification Program (or progressing through GSK’s ACP program) or via an external certified body.
• Experience managing the interface with stakeholders (Site Directors, Site Quality Directors, Heads of Support Functions).
• Ability to utilize critical thinking of complex quality systems and processes.
• Understanding and experience of corporate governance processes.
• Understand or have a background in New Product Introduction requirements.
• Risk Management knowledge, application and evaluation.
• Application of continuous improvement, change control and risk assessment.
• Reading and verbal multiple language communication skills is considered an advantage.
Job ID : 282436
Experience : 5 years
Location : Worli Mumbai, Nashik
Industry Type : Pharma / Healthcare / Clinical research
End Date : 30th March, 2021
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