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| Job Location | Mysore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | FMCG / F&B |
| Functional Area | General / Other Software,Quality (QA-QC) |
| EmploymentType | Full-time |
PRIMARY RESPONSIBILITIES Assure that CRO Operations remains in compliance with corporate policies and procedures and all applicable worldwide regulations & guidelines. Deploy, Manage & improve quality management system and create awareness across the organization. Plan & roll out regulatory readiness program for eventual regulatory audits. Ensure effective execution of the readiness program. Assess the effectiveness of inspection readiness by coordinating and conducting internal and external compliance audits and applicable assessments (e.g. inspection readiness assessments). Provide consultation to operations & business enabling functions personnel on Requirements (Organization, regulatory & client) & compliance issues. Impart awareness session on applicable regulations (FDA, MHRA etc.). Lead cross-functional teams to help identify potential issues and resolve current issues. Manage compliance issues across organization and escalate issues to Bioclinica QA management as appropriate Directly manage & coordinate internal and external compliance auditing programs at Bioclinica. Support Operations staff in the use of integrated quality systems; summarize quality reports and provide quality metrics as appropriate. Oversee CAPA management & facilitate effective corrective and preventive action (CAPA) closure.Specialized knowledge and skills: Quality Assurance / Quality Management space in Clinical Domain, especially in Pharmacovigilance /Data Management / Safety areas. Sr. auditor with Gxp audit experience auditing internal & external systems. Hands on experience and subject-matter-expertise in Clinical Data Management / Life Cycle Safety / Pharmacovigilance. A key contributor in Driving the Organization Towards Pharmacovigilance/Data Management/Safety Regulatory Audits & Inspections. GVP/GCP/GXP Certification, ISO, ISMS Knowledge preferredQUALIFICATIONSEducation: Degree in pharmaceuticals/ Medical/life science; or Engineering degree with work experience in core Clinical Domain (Master s degree preferred)Experience: 6-8 years of relevant experience.Additional Skills Strong motivational skills and abilities, promoting a team-based approach Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills Goal-oriented Ability to maintain professional and positive attitudeWORKING CONDITIONSTravel: 0-50% (can be adjusted)Lifting: 0-50 lbs. (can be adjusted)Other: Computer work for long periods of timeTHIS JOB DESCRIPTION SHOULD NOT BE DEEMED ALL-INCLUSIVE. ADDITIONAL REQUIREMENTS AND EXPECTATIONS MAY BE ASSIGNED. AT ALL TIMES, EMPLOYEES ARE EXPECTED TO ADHERE TO COMPANY POLICIES AND COMPANY SOPS.EEO StatementBioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.Collaboration, Continuous Learning, Critical Thinking, Organizational Awareness, Results Orientation, Service Orientation,
Keyskills :
clinical data managementquality management systemlife cycleqa managementclinical datadata managementquality systemsquality assurancepreventive action