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Product Quality and Safety Manager require at Roche

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Product Quality and Safety Manager require at Roche

Roche has established Global Analytics and Technology Center of Excellence (GATE) at Chennai to drive analytics and technology driven solutions by partnering with Roche affiliates across the globe.  As an Analyst / Sr Analyst, you will work closely with stakeholders in the business teams across Roches global affiliates and deliver high quality analytics solutions to real-world business problems.

Post : Manager - Product Quality and Safety

Job Description
• Establishment and safeguarding of the local QMS to ensure compliance with internal (Roche Policies, Divisional Quality Standards) and external requirements (ISO 13485, ISO 9001, local regulation) within Operations and other QM-relevant processes.
• Monitoring of the effectiveness and efficiency of the local QMS together with its continuous improvement by usage of performance indicators and QM-reports as well as the establishment of specific training measures and seek opportunities to continuously improve understanding, performance and quality of complaint documentation, processes and procedures.
• Maintenance QA-related process, such as training, supply chain management, complaints management aligning with global team meeting requirements of standard.

• Setting quality guideline for local distribution practice to be implemented and adhered to ensure no risk to product quality during local handling and transportation so as to ensure Product quality is not impaired.
• Handling Quality related processes like product Recall, Handling Notifications, Adverse Events.
• Compilation, review and release of QM manual and other documentable procedures.
• Responsible for performing various quality audits like internal audits/supplier audit/distributor audit/ managing CAPA and closure.
• Responsible for leading complex cross-functional process improvement projects, mentoring key Quality process improvement projects, preparing organization for ISO 13485
• Understanding customer need for quality, collaborating with internal team to build capability and collaboration skills, communicating/coordinating/bringing together key stakeholders, proactively resolving conflicts, delivering Operational Excellence training and value-add sustainable solutions to drive quality projects.


Candidate Profile
• You will have a successful and considerable proven track record in leading people, preferably acquired in the healthcare industry. To be considered for this role, you will need a Degree educated or equivalent in engineering, scientific or related field and to evidence your success in service delivery; a proven track record of developing strong relationships with key stakeholders to the highest decision making level leading to successful business outcomes. A strategic thinker with an entrepreneurial spirit and the ability to prioritize and deliver, you can drive change and adoption of new concepts.
• With confidence and passion, you will have excellent written and verbal communication skills, and be able to communicate with maximum impact.

• Resilient, tenacious, you strive under pressure, working effectively as part of a close-knit team in a fast-paced, time-sensitive environment with shifting priorities and multiple deadlines. With strong analytical skills, you are at ease working with technical and scientific information.
• This position offers exposure to wider Roche organization at all levels and therefore you must have the qualities to make a positive, professional impact in a matrix environment and win the hearts and minds internally.
•  Preferably from In-vitro diagnostics and medical devices industry, Pharmaceutical industry ( non-manufacturing QMS setup) Expertise in Cold Chain Management, Experience in certification agency


Additional Information
Qualification : M.Sc / M.Pharm., / B.Pharm
Location : Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Product Quality and Safety
End Date : 30th October, 2021

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