Merck KGaA

Senior Manager Quality

Posted On

Sept. 19, 2024

Location

Bangalore, Karnataka

Experience Level

E - Professional (10+ years)

Job Type

full-time

Apply By

Oct. 8, 2024

Job Description

Title: Quality ManagerDevelop the Quality strategy, CAPEX and OPEX plan which meet the business need.Design, recruit and manage QA/QC organization in Jigani site. Ensure the resource needed for the quality operation is available. Implement the quality policy and quality objective which compatible with the context and strategic direction of the organization; Implement the GMP objective .Ensuring the quality of product and service consistently provided to meet the customer and applicable statutory and regulatory requirements. Ensuring the customer requirements for the GMP are confirmed, understood and met by the organization.Ensure the quality responsibilities and authorities for relevant roles are assigned and communicated within the organization.Report the QMS for the site management review at the planned intervals, to ensure its continuing suitability, adequacy and effectiveness.Responsible for all verification/validation /Qualification activities in Jigani site.Ensure the quality compliance with global and local regulations for the projects/Tech Transfer and opearations in Jigani site.Responsible for acquiring all related ISO certificates for Jigani.Responsible for Supplier quality management with procurement for materials qualification and supplier audits.Strictly comply with company EHS safety regulations for QA/QC operations in Jigani site. Hands on experience of running all QC equipment like GC, HPLC, NMR, LCMS, CHNS, ICP, IR spectra, etc Who you are:Education: Master in Science or above.Working Experience: 15 years+ QC/QA experience in Chemistry Pharmaceutical, or equivalent field5 years+ experience of QC/QA managerProject (multi-function team) leadingTechnical & Professional Knowledge: Quality Management (GMP and ISO9001:2015 ,ISO 17025 :2017, ISO: 17034 knowledge) Team Leading skillsProject management skillsAnalytical skills Problem solving skillsFluent in English

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