Our client, a leading Pharma company is looking for an External Supply Quality consultant. He/she is responsible for the Quality management of contract manufacturers, packagers, and supply partners globally.
The position has responsibility for the effective Quality Assurance Management oversight of the clients partners and suppliers who manufacture and package Pharmaceutical products. The position is accountable for providing quality assurance management of key contractors and suppliers for the client and for assuring that the products supplied to our patients are manufactured, tested in accordance with c-GMPs, the registration file and country specific requirements.
•Responsible for the effective Quality Assurance Management oversight of the assigned contractors and suppliers who manufacture drug products and supplies material to the client.
•Provide effective Quality point of contact role and responsibilities in the cross functional virtual site operating teams (VSOT) of assigned contractors/suppliers.
•Lead the implementation and support of Quality Assurance/Quality Control systems for drug products, raw materials manufactured and supplied by the Contract partner/supplier.
•Develop and negotiate quality agreements.
•Support the development, implementation and continuous improvement of Quality Systems to support the client internal and regulatory requirements.
•Proactively support MSQA and regulatory inspections at vendors and ensure tracking of Corrective and Preventative actions (CAPA).
•Provide Quality guidance for significant deviations at contractor sites.
•Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities.
•Lead quality risk management activities and manage mitigation plans within partners and suppliers.
•Interactions with many internal business and manufacturing organizations (e.g., ES, GTS, CMO, Procurement, Regulatory Affairs)
•Min Master of Science, or Bachelor of Pharmacy
•5 years’ experience in a GXP setting.
•At least 4 years of Product Quality Assurance experience in a GMP environment
•Experience with external suppliers/contractors
•Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, Documentum platforms
•Command of English language and multi-lingual is beneficial.
•Good verbal and written communication including presentation skills
•Ability to prioritize work, to act and work independently and to report items as required to Team leader
•Take initiative and be proactive
•Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor
•Has a broad GMP and technical know-how to handle emerging issues