- 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 Qinecsa QA management as appropriate.
- Directly manage & coordinate internal and external compliance auditing programs at Qinecsa.
- 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.
- Reading, understanding, and adhering to organizational standard operating procedures (SOPs)
- Assisting in establishing and enforcing departmental standards
- Working with internal staff to resolve issues
- Exploring new opportunities to add value to organization and departmental processes
- Helping others to achieve results
- Performing other duties as assigned
- Attending and participating in applicable company-sponsored training
- Strong motivational skills and abilities, promoting a team-based approach
- Strong interpersonal and communication skills, both verbal and written in English
- Strong organizational and leadership skills
- Goal-oriented
- Ability to maintain professional and positive attitude
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Quality Assurance Lead - India - Qinecsa Solutions
Description
Job Title: Lead, Quality Assurance & Regulatory Compliance
Primary Responsibilities
Secondary Responsibilities
Maintain quality service and departmental standards by:
Contribute to team effort by:
Maintain technical and industry knowledge by:
Qualifications
Education : Bachelor's or Master's degree in Pharma/ life sciences or equivalent in a related discipline
Experience : 6-8 years of relevant experience
Additional Skills
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Quality Assurance Lead
Only for registered members India
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Lead, Quality Assurance
Only for registered members India
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Lead, Quality Assurance
Only for registered members India
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Lead Quality Assurance Tester
Sodexo- India
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Lead Quality Assurance Engineer
Only for registered members India
-
Quality Assurance Test Lead
MethodHub- India
-
Quality Assurance Engineering Lead
Only for registered members India
-
Medical Device Quality Assurance Lead
Only for registered members India
-
QA Lead
Freelance Only for registered members India
-
Global Head-IT Service Assurance
Only for registered members India
-
Project Engineer
Full time Only for registered members India
-
QA Manager
Only for registered members India
-
Oracle Project Manager
Freelance Only for registered members India, India, India
-
quality assurance
Only for registered members India
-
Lead Automation Engineer
Only for registered members India
-
QC Manager, Bedding
Full time Only for registered members India
-
Python Developer
Only for registered members India
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Lead Risk
Only for registered members India
-
Salesforce Project Manager
Full time Only for registered members India
-
QA Test Engineer
Only for registered members India