Quality Assurance Management Specialist

1 week ago

hubballi, India beBeeCompliance Full time

Job Summary:This Quality Assurance Management Specialist role involves ensuring compliance with corporate policies and procedures, as well as worldwide regulations and guidelines. The ideal candidate will have strong leadership and organizational skills, along with excellent communication and interpersonal abilities.Main Responsibilities:Ensure quality management system 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 QA management as appropriate.Directly manage & coordinate internal and external compliance auditing programs at an organization.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.Secondary Responsibilities:Maintain quality service and departmental standards by:Reading, understanding, and adhering to organizational standard operating procedures (SOPs)Assisting in establishing and enforcing departmental standardsQualifications:Bachelor's or Master's degree in Pharma/ life sciences or equivalent in a related discipline6-8 years of relevant experienceAdditional Skills:Strong motivational skills and abilities, promoting a team-based approachStrong interpersonal and communication skills, both verbal and written in EnglishStrong organizational and leadership skillsGoal-orientedAbility to maintain professional and positive attitude

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    hubballi, India beBeeSpecialist Full time

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    hubballi, India beBeeQuality Full time

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    hubballi, India beBeeSoftwareQuality Full time

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    hubballi, India beBeeAssurance Full time

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    hubballi, India beBeeSeniorQualityAssurance Full time

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