MSD Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Post : Assc Dir, Quality Systems & Compliance
Job Responsibilities
• Schedule and perform assigned audits and ensure timelines for audit steps (pre-work, conducting audit, issuance of audit report, CAPA receipt) meet established expectations. This requires approximately 50% worldwide travel.
• Review and approve audit reports.
• Maintain a broad based expertise of cGMP's, MSD Policies, Procedures and Guidelines, regulatory requirements, etc. that are pertinent to the pharmaceutical industry including, but not limited to Biologics, Medical Devices, Vaccines, Small Molecules, Combination Products, APIs and Controlled Substances.
• Obtain and maintain cutting-edge knowledge, application, and certification status for various technical/Quality auditing topics
• Maintain awareness of evolving industry and regulatory trends/regulations. Support New Business opportunities through Due Diligence (electronic due diligence as well as on-site visits) and Pre-Contract Audits, issuance of reports, and evaluation of corrective and preventive actions. Assist with preparation of annual audit schedule, using risk based approaches for auditor assignment
• Lead & Coordinate with Procurement and impacted Site Quality leads on critical audit findings and or audit refusals. Generate comprehensive presentations/summary of issues for effective communication to all levels, ensuring required assessments are performed.
• Provide regulatory inspection support to MSD Sites as it relates to the Global cGMP & Compliance Auditing program, status of audits, and specific audit results.
• Provides support and administrative functions for the electronic Supplier Tracking and Repository System, and assists in data maintenance.
• Leads initiatives / drive results in various projects, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet using site, management and regulatory expectations.
• Mentor new auditors to ensure comprehensive training and full understanding of auditor roles and responsibilities and associated strategic/tactical thinking.
Candidate Profile
• Bachelors Degree in Pharmacy, Chemistry, (Micro-) Biology, Chemical Engineering (or equivalent).
• Minimum of 8 years of manufacturing, technology, and/or quality operation experience within an EU/FDA, API, Drug Product, Medical Device or equivalent environment.
• Quality/compliance experience in an EU/FDA regulated industry.
• Experience performing audits of external and internal manufacturers and testing laboratories.
• Thorough understanding of Quality Management Systems and process to support the manufacturing of API’s, drugs products, and medical devices, including risk management.
• Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
• Ability to work independently with limited supervision in a virtual-management environment.
• Must possess “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas; Medical Device/Combination product, Biologics, Vaccines, API’s, Non-sterile Drug Product or Sterile Drug Product manufacture.
• Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization
• Must have the ability to travel globally approximately 50% of the time
• Bachelors Degree in Pharmacy, Chemistry, (Micro-) Biology, Chemical Engineering (or equivalent).
• Minimum of 8 years of manufacturing, technology, and/or quality operation experience within an EU/FDA, API, Drug Product, Medical Device or equivalent environment.
• Quality/compliance experience in an EU/FDA regulated industry.
• Experience performing audits of external and internal manufacturers and testing laboratories.
• Thorough understanding of Quality Management Systems and process to support the manufacturing of API’s, drugs products, and medical devices, including risk management.
• Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
• Ability to work independently with limited supervision in a virtual-management environment.
• Must possess “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas; Medical Device/Combination product, Biologics, Vaccines, API’s, Non-sterile Drug Product or Sterile Drug Product manufacture.
• Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization
• Must have the ability to travel globally approximately 50% of the time
Preferred:
• External engagement in regulatory or industry forums.
• Current with regulatory expectations and requirements.
• Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
• Demonstrated ability to lead and drive results/impact for critical business / compliance initiatives.
• Demonstrated ability for process improvement and to create/implement simple, compliant systems in a diversity of areas.
• Experience with direct participation on interdisciplinary Due Diligence teams – with Senior Management, inclusive of initial risk/compliance assessment based on documentation.
• Lean six-sigma belt / demonstrated process improvement experience.
• Knowledge and expertise in application of Quality Risk Management pertaining to auditing, above-site function/processes, or technical areas.
• Knowledge of Quality By Design development & submission requirements
• Experience with development, implementation and optimization of IT tools to deliver business outcomes/impact.
• External engagement in regulatory or industry forums.
• Current with regulatory expectations and requirements.
• Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
• Demonstrated ability to lead and drive results/impact for critical business / compliance initiatives.
• Demonstrated ability for process improvement and to create/implement simple, compliant systems in a diversity of areas.
• Experience with direct participation on interdisciplinary Due Diligence teams – with Senior Management, inclusive of initial risk/compliance assessment based on documentation.
• Lean six-sigma belt / demonstrated process improvement experience.
• Knowledge and expertise in application of Quality Risk Management pertaining to auditing, above-site function/processes, or technical areas.
• Knowledge of Quality By Design development & submission requirements
• Experience with development, implementation and optimization of IT tools to deliver business outcomes/impact.
Additional Information
Experience : 8 years
Qualification : B.Pharm, B.Sc
Location : Mumbai
Industry Type : Pharma
Functional Area : Quality Systems & Compliance
End Date : 5th June, 2018
Experience : 8 years
Qualification : B.Pharm, B.Sc
Location : Mumbai
Industry Type : Pharma
Functional Area : Quality Systems & Compliance
End Date : 5th June, 2018
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