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Post: Sr. Manager, EQA - D&L
Position Overview - Basic Functions & Responsibility Essential functions include, but are not limited to
Ensure that all products are stored and distributed in accordance with all applicable MSD and regulatory requirements to meet both internal and external customer demands, the Product License, GDPs and contractual obligations.
Ensures the quality performance of the D&L network and external partners through direct oversight, support and technical advice, counselling to the partners' site leadership and providing on-site supervision as appropriate. This includes executing activities such as Partner Selection and GDP Due Diligence including establishing Quality Agreements; Quality Assurance including permanent audit readiness, tracking partner Quality metrics, providing coaching and training; Quality Control such as atypical investigations and change control requests. This also includes providing support to build effective quality systems at the partner and supporting continuous improvement activities.
Primary Activities Primary activities include, but are not limited to:
• Reports to the AP External Quality Assurance – D&L Assoc. Director, for general advice and instruction concerning Quality Operations, but functions independently. Receives guidance, management, and direction and when necessary; executes all responsibilities independently. Keeps the AP EQA-D&L Assoc. Director informed on the status of operations and when challenges, opportunities and/or issues arise.
• Directly works with an experienced team of Quality professionals in both the internal and the external network to ensure the compliant and reliable supply of MSD's products to MSD's patients. Performs the responsibility of the MSD Quality point of contact for the external partner and acts as a liaison for contact and communications between the partner and internal MSD personnel in the region.
• Works with the Global Logistics and any External Partner to ensure that effective and robust Quality Systems and Quality management are in place for D&L activities. Ensures on-site guidance is available in the preparation of metrics, procedures and guidelines where warranted. Ensures proactive support in training and coaching to initiate quality improvements within Operations and Quality.
• Assures the development and maintenance of a Quality Agreement with the external partners. Acts as the point-of-contact during contractual negotiations. Provides input into the development of commercial contractual agreements with the external partners on quality related terms.
• Ensures appropriate investigations are conducted by the external partners' operations into abnormal operational occurrences such as product inventory rejections, atypical events, customer complaints, temperature excursions etc. Coordinates support from appropriate staff groups and recommends corrective measures; assists in the coordination of significant investigations including Fact Findings and the coordination of product recalls as needed.
• Assures QO requirements on Change Requests submitted by the partners and/or MSD are appropriate and conform to all requirements.
• Participates in quality due diligence assessments for pre-approval considerations of new external partners within his/her area. Ensures support to the partner in remediation of due diligence and/or pre-contract audit gaps. Supports CAPA development with partner in support of GMP audits. Ensures audit follow-up to oversee that corrective actions are implemented in a timely manner where warranted.
• Leverages the Global Logistics functions within the internal network to support the D&L business.
• Bachelor degree in Chemistry, Pharmacy, Biology, Microbiology, Logistics, Supply Chain Management, or Engineering;
• 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 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;
• Strong demonstrated interpersonal, communication, and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations would be preferred. Able to handle organisational complexity and ambiguity is preferred.
• Must have exemplary people/team collaboration experience, including speaking candidly.
Experience: 4-6 years
Qualification: B.Pharm, B.Sc
Last Date: 30th December, 2015
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