Excellent verbal and spoken communication skills with in depth knowledge in GCP and CRF part 11 and experience in CSV Job Description : - Taking on a management role in process definition or re-engineering for continuous improvement of operating procedures and processes. - Providing value-added, day-to-day support, guidance, and direction to the operation teams on matters of regulatory and process compliance in service of clinical trials. - Organization, performing and supporting regular audits at assigned locations. - Aligns QA resources towards specific functional efforts to improve operational effectiveness and consistency, efficiency, and quality of delivery. - Able to combine strategy with conventional and unconventional thinking to form innovative, yet compliant solutions. - Examine current landscape to determine where new or updated processes may provide value added benefit, risk reduction, and efficiencies. - Serve as key escalation and QA contact globally with focus on assigned/regional office locations. - Provide guidance and direction to key operational and delivery stakeholder sin matters of compliance and best practice. - Shared ownership in the development, implementation, and maintenance of Cenduit's Quality System, including facilitating process improvement activities to the product and project teams for continuous improvement. - Ensures progress of related staff towards individual and departmental goals and initiatives and ensures staff qualifications remain current to defined standards. - Assists in definition, execution, and reporting of department objectives and assigned initiatives. - Proactive monitoring of compliance with Quality System reviews, Corrective And Preventive Actions, training, internal auditing, and supplier management. - Conduct ongoing training and support for new and existing staff on the Quality Manual and other key areas including Corporate SOPs, GCP, 21 CFR Part 11, validation, and process improvement/problem solving. - Host customer audits as needed. Participate/support whenever required. - Perform internal audits to ensure that Quality Standards are being adhered to. - Assist in the maintenance of the corrective/preventive action program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion and periodic reports and metrics. - Participates in the evaluation of quality events, incidents and possible complaints or compliments and the follow-up events. - Keep up to date with all related quality legislation and compliance issues. - Represent the company during external inspections as required. - Perform Vendor Evaluation / Vendor audits as required. - Liaise with customers and suppliers where necessary (where impacting/affected by quality issues). - Expected and empowered to make decisions without direct supervising. Skills and Competencies: - Strong problem solving/process improvement skills with ability to be part of and own solutions. - Drive to seek solutions with intent and priority through a balance of creativity and restraint. - Comprehensive understanding of quality management systems initiatives and standards, including experience in writing policies and procedures. - Demonstrated expertise with computerized systems validation methodologies and related industry expectations. - Good working knowledge of industry regulations and their applicability to the work performed by Cenduit. - Established client facing communication skills - ability to manage situations, negotiate conflicts, and influence others to achieve objectives. - Significant experience in hosting and/or conducting audits of computerized systems with clinical trial relevance. Intermediate familiarity with computerized systems validation methodologies. Education & Experience: - Bachelor's Degree/PG in scientific field or equivalent. - Min 10+ year's experience working within a regulated environment with in depth familiarity with (5 Yrs) in FDA and international regulations such as 21 CFR Part 11, GCP/E6, - EU Directive 95/46/EC, etc. Prior regulatory inspection history strongly desired. - Prior management experience.

Bangalore

Senior Manager - Quality Assurance - Clinical Research 

Senior Manager - Quality Assurance - Clinical Research  ,Job Description for Senior Manager - Quality Assurance - Clinical Research  in HR Logica in  Bangalore for (10-17) years of experience. Apply Now!

Job Description for Senior Manager - Quality Assurance - Clinical Research  in HR Logica in  Bangalore for (10-17) years of experience. Apply Now!