Compliance Lead Cork

Recruiter
Cognizant
Location
East of England
Salary
Competitive
Posted
14 Sep 2020
Closes
12 Oct 2020
Employer Sector
Banking & Finance - Retail
Contract Type
Permanent
Hours
Full Time
Travel
None

Excellent opportunity for a Compliance lead to be part of our Quality Assurance and Engineer practice based at key clients in Cork.

Key Responsibilities :

?? Create/update the QMS and all Validation and compliance SOPs

?? Perform GxP/Validation assessments and generate reports

?? Create/develop Compliance Strategy, Validation/Quality plans

?? GxP document reviews with Pharma industry experience

?? Change management, CAPA, Deviation, Periodic GxP reviews

?? Moderation, co-ordination with stakeholders on RCA, Investigations of Deviations or non-compliances for all GxP compliances

?? Direct interaction will client and stakeholder management

?? Demand Management, Team management, Trainings

?? Track onboarding, training of all project/program stakeholders until closure

?? Ensure deviations and CAPA are raised for any issues/defects and work with customer compliance QA for closure

?? Documentation as per GDP practices

?? GCP, GMP practices, integration with instruments, devices, software's within manufacturing environment, clinical labs

Key Kills And Experience :

?? Experience in LS industry in Regulatory Compliance roles

?? Experience in Creating/updating the QMS and all Validation and compliance SOPs

?? Experience in Performing GxP/Validation assessments and generate reports

?? Create/develop Compliance Strategy, Validation/Quality plans

?? GxP document reviews with Pharma industry experience

?? Experience on Change management, CAPA, Deviation, Periodic GxP reviews

?? Experience on moderation, co-ordination with stakeholders on RCA, Investigations of Deviations or non-compliances for all GxP compliances

?? Proficiency in oral, written communications

?? Experience in direct interaction will client/compliance team and with good Interpersonal skills

?? Good knowledge on six sigma, LEAN Six Sigma, Statistical Analysis

?? Experience in direct interaction will client and Interpersonal skills, stakeholder management

?? Experience in Demand Management, Team management, Trainings

?? Attention to detail and ability to question stakeholders on compliance gaps if any and provide recommendations on filing those gaps

?? Track onboarding, training of all project/program stakeholders until closure

?? Ensure deviations and CAPA are raised for any issues/defects and work with customer compliance QA for closure

?? Good documentation skills as per GDP practices

?? Good understanding of GCP, GMP practices, integration with instruments, devices, software's within manufacturing environment, clinical labs

?? Knowledge on ISO 13485 and ISO 27001, 21 CFR Part 820

?? Willing to work at manufacturing site and establish client..... click apply for full job details