Teva Senior Manager Commercial Quality 

Malaysia, Penang, George Town 

83254509

• Serves as a Subject Matter Expert on all In-Take Team complaint processes and scenarios and assists QAS employees to ensure compliance with Quality Assurance Services Standard Operating Procedures and Work Instructions.
• Identify by way of peer/site/management feedback, any discrepancies or limitations of existing procedures. Discuss, vet and implement solutions for continuous improvement by way of SOP/WI revisions, automation of QAS applications, refresher trainings and/or process tests.
• Liaise with allied departments on any issues arising from incoming reports and work towards appropriate resolution.
• Responsible for handling High Profile complaints in a timely and accurate manner. Ensure that proper justification is provided for and documented in all High Profile complaint files related to decisions for elevating to a Field Alert Report ( or not) and any relevant concerns are highlighted to Senior QAS management immediately.
• Responsible for managing the training/retraining of (new and existing) employees in all aspects of QAS In-Take Team including processes (SOPs/WIs), product knowledge, liaising with manufacturing sites, coordinating the return of complaint samples, use of the phone system and customer service etiquette. Accountable for getting new employees up to speed and contributing to the success of the Team in a minimum time frame.
• Processing complaint records to demonstrate usage of QAS systems to trainees and implementation of SOP/WI procedures. Making outbound calls to complainants to demonstrate call handling procedures and best practices to trainees.
• Monitoring assignment of complaints to trainees basis their progress during the training phase and reviewing each record to discuss gaps and/or share best practices.
• Participate in the continuous improvement of the QAS Group to drive operational excellence by performing a variety of tasks and projects to increase compliance, efficiencies and effectiveness of actions within the Group.
• Tasks and Projects may include but are not limited to: Conducting internal self-assessments of various processes within QAS and connecting processes with other Business Partner groups Support audits and inspections of QAS group. Initiating, driving and completing projects spanning manufacturing/packaging sites, allied departments to calibrate QAS processes/data such as QPIS data, site notification addresses and contact numbers. Track wise notification receipts, new product launches, site transfers

• Bachelors of Science Degree in a scientific field preferably, Pharmacy, Chemistry, Micro-Biology, Chemical Engineering, etc
• Minimum 8 years of related experience in Pharmaceuticals/Pharmaceutical QA related job profiles is required that
• should include a significant period working across cross functional teams distributed across geographies
• Training is required in the Code of Federal Regulations, Current Good Manufacturing Practices, Teva’s Policies and Procedures – especially related to processing of Product Quality related Complaints and Adverse Events; Good Documentation Practices; Deviations/Investigations/Root Cause Analysis, CAPA; Data Integrity, Track Wise; MS-EXCEL, MS-Word, MS-Power point, MS-Visio
• Training in manufacturing, packaging and laboratory testing of different dosage forms is beneficial and highly desired
• Skills related to working across cross functional teams distributed across geographies
• Leadership skills, performance management, conflict management etc.
• Previous experience with cGMPs, good written and verbal communication skills, the ability to create and present training materials, to work independently, and manage multiple possibly conflicting priorities are required to perform the job.
• Experience at a pharmaceutical/biopharmaceutical/medical device manufacturing/packaging/testing facility is
• especially useful and desired.

Director Commercial Quality North America

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