AS Talent HUB
Drop your resume:
Email ID: [email protected]
Contact NO: 8828054648
Job Title: Unite Manager – External Quality Assurance
Salary: 20 to 22 LAKH PER ANNUM
INDUSTRY: International organizations, healthcare partners, or pharmaceutical companies.
Job Location: Churchgate, India
Department: Quality Assurance (QA)
Reporting to: Head Quality Affairs India
Employment Type: Full-Time
Working days: 5 days
Turnover: 5000 Cr
HO: Netherland (Europe)
About the Role
We "AS Talent HUB" Mumbai based consultancy are looking for an experienced Manager – External Quality Assurance to lead quality oversight for outsourced laboratories, inspection agencies, and external quality partners. The ideal candidate will have a strong pharmaceutical quality background, excellent stakeholder management skills, and hands-on experience with international quality standards.
This role requires close collaboration with internal teams and external partners to ensure compliance, quality excellence, and continuous process improvement.
Key ResponsibilitiesStakeholder & Partner Management
- Develop and maintain strong relationships with outsourced laboratories, inspection agencies, and other external quality partners.
- Coordinate effectively with domestic and international stakeholders.
- Manage contracts and performance of contract laboratories and inspection agencies.
- Conduct regular business review meetings with external partners.
- Prepare reports, presentations, business updates, and quality review documents.
- Support continuous improvement initiatives within the Quality Assurance function.
Quality Assurance
- Ensure timely preparation and review of analytical methods, analytical protocols, and method verification protocols.
- Review and approve method verification reports generated by contract laboratories.
- Provide timely support for analytical queries and Out of Specification (OOS) investigations.
- Ensure compliance with applicable quality procedures and regulatory requirements.
Audits & Compliance
- Plan and perform verification audits of outsourced laboratories.
- Monitor compliance with Quality Management Systems and regulatory requirements.
- Support ISO 9001, ISO 14001, ISO 13485, and EU GDP quality standards.
Complaints & Deviations
- Manage quality complaints related to assigned product categories.
- Ensure timely investigation, documentation, and closure of deviations.
- Support corrective and preventive actions (CAPA) and continuous quality improvement initiatives.
Candidate Profile
- Bachelor's or Master's Degree in Science, Pharmacy, or a related discipline.
- Minimum 10 years of experience in Quality Assurance within the pharmaceutical industry.
- Experience working with outsourced laboratories, inspection agencies, or international quality partners.
- Strong understanding of Quality Management Systems, analytical testing, audits, and compliance.
- Knowledge of ISO 9001, ISO 14001, ISO 13485, and EU GDP guidelines.
- Excellent communication, presentation, and stakeholder management skills.
- Fluent in English (written and spoken).
Preferred Skills
- Leadership and team collaboration
- Analytical thinking and problem-solving
- Audit and inspection readiness
- Strong documentation and reporting skills
- Ability to work with cross-functional and international teams
Why Join Us?
- Opportunity to work with global quality standards.
- Exposure to international quality systems and external quality partners.
- Dynamic work environment with opportunities for professional growth.
- Competitive compensation and career advancement.
If you are passionate about Quality Assurance and have experience managing external quality operations, we'd love to hear from you. Apply now!
Pay: ₹2,000,000.00 - ₹2,200,000.00 per year
Benefits:
- Cell phone reimbursement
- Health insurance
- Leave encashment
- Paid sick time
- Provident Fund
Work Location: In person
