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Post : Assoc. Dir, External Quality
The primary purpose of the position is to support quality assurance functions required for the “Fortify our Future”, API Restructuring Project. The incumbent is responsible for supporting supplier selection and qualification and providing quality support for product transfers, process validations and performing overall quality oversight of API manufacturers.
The incumbent’s role is to ensure that all products or materials supplied are manufactured, packaged, analysed and distributed in conformance to company and regulatory guidelines and meet both internal and external customer demands. This is done through direct support and technical advice, guidance, and counselling to the external party quality representative. The incumbent exercises a coaching role in guiding the external party to comply with Current Good Manufacturing Practices regulations and other pertinent legal requirements.
• Reports to the Director, Supplier Quality Assurance for External Manufacturing (Animal Health) and is a member of the Quality External Manufacturing team. Receives guidance and direction when necessary; discharges all responsibilities independently. Keeps the Director informed on the status of operations and when challenges, opportunities and/or issues arise.
• Performs due diligence and qualification audits to determine suppliers to be selected for the restructuring program. Reviews and approves process validations and equipment qualifications as needed to support multiple product transfers.
• Assures that the external partner operates within the agreed upon GMP policies and procedures (or other applicable regulations) and in accordance with the Quality elements of the Commercial Agreement and the Quality Agreement. Ensures the Quality Agreements are kept up to date and ensures review of the Quality elements in the Commercial Agreement.
• Acts as Merck-AH Quality Assurance point of contact for defined key suppliers and as the Quality liaison between the external partner and the internal company personnel.
• Supports Merck Animal Health audit plans and effective execution of subsequent remediation by the partner for observations identified.
• Conducts regular site visits to support training and coaching to initiate quality improvements within the partners’ operations where necessary.
• Assures quality requirements on change proposals submitted by the partners conform to all requirements.
• Reviews all deviation investigations submitted by the partners and supports further investigation where necessary.
• Support Product Quality Complaint (PQC) investigations with the relevant suppliers
• Support technology transfer projects for the relevant suppliers
• Assures guidance is provided to the partner in the preparation of quality systems, procedures and guidelines as applicable
• Support effective preparations at the external party for regulatory inspections (where required).
• Effectively contributes to cross-functional investigations and project teams.
• Completes additional quality related activities as required to fulfil the role.
• Bachelor’s degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering, or equivalent
• Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
• Must have the ability to travel globally approximately 50% of the time.
• Must have English language capability preferably with a second language
• Must have excellent problem-solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management principles
• Must have the ability to influence management of complex manufacturing operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
• Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMPs and regulatory issues
• Must have the ability to work independently with limited supervision in a virtual-management environment.
• Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations.
• Preferable to have auditor training (example ISO 9001)
• Advantageous to have Qualified Person eligibility if located in Europe
• External engagement in regulatory or industry forums.
• 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.
Qualification : B.Pharm, B.Sc
Location : Pune
Industry Type : Pharma
Functional Area : External Quality
End Date : 25th October, 2019
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