Location
Mumbai | India
Job description
- The primary purpose of the GMP Audit Manager is to perform and manage GMP compliance audits of Biopharm, Vaccines and Pharmaceutical facilities supplying highly regulated markets
- In this role, you will provide additional sterile manufacturing subject matter expertise within the GSK Pharma Supply Chain Asia auditing team
- You will be responsible for evaluating the level of compliance of GSK Global 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
Location: This position will be located at the GSK Worli Mumbai HQ or a GSK India manufacturing site facility subject to further discussion and agreement.
Travel: Approximately 40 to 50% travel is required.
Application Cover Letter: Please support your application with a cover letter detailing how your skills and experience meet the role requirements.
Key Responsibilities:
- 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.
More experienced staff may undertake:
- 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 Global 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.
Basic Qualifications
- Bachelor of Science degree in a Scientific and/or Engineering discipline.
- Demonstrable Pharmaceutical/ Biopharm/ Vaccines subject matter expertise (or a technically similar discipline).
- Minimum 10 years experience in the pharmaceutical / biopharma / vaccines industry including 5 years experience specifically in Biopharm / Vaccines / Steriles / Aseptic related industries.
- Experience with and 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.
Preferred Qualifications
- Broad based understanding of Primary and Secondary Pharmaceutical / Biopharma / Vaccines 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.
Why GSK
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
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