
Team Lead
16 hours ago
Role & responsibilities
- Lead, mentor, and manage the Pharmacovigilance QA team to ensure effective execution of QA activities.
- Develop, implement, and maintain QA processes, procedures, and tools aligned with regulatory guidelines (e.g., ICH, FDA, EMA).
- Monitor and ensure compliance of pharmacovigilance activities with applicable regulations and internal SOPs.
- Conduct risk assessments and develop mitigation plans to ensure PV compliance.
- Oversee the management and closure of CAPAs (Corrective and Preventive Actions) following audits or inspections.
- Plan, coordinate, and conduct internal and external audits of PV processes, systems, and vendors audits (Risk Based Audit approach).
- Lead audit preparedness activities and ensure timely resolution of audit findings.
- Collaborate with cross-functional teams to implement audit recommendations and continuous improvements.
- Maintain audit documentation and track audit metrics for management review.
- Ensure all QA activities support compliance with global pharmacovigilance regulations, including GVP (Good Pharmacovigilance Practices).
- Participate in regulatory inspections and provide QA support as needed.
- Review and approve quality documentation related to PV activities such as SOPs, training materials, and audit reports.
- Identify QA training needs for the PV team and develop training programs accordingly.
- Conduct and coordinate training sessions on quality standards, SOPs, and compliance requirements.
- Promote a quality culture and awareness within the PV department.
- Identify gaps and areas for improvement within PV and QA processes and implement best practices.
- Collaborate with PV operations and other departments to optimize workflows and enhance quality outcomes.
- Utilize metrics and KPIs to monitor quality performance and drive continuous improvement.
- Act as the key liaison between PV, QA, regulatory affairs, and other stakeholders.
- Provide guidance and support on quality-related matters to internal teams and external vendors.
- Facilitate effective communication to ensure alignment on quality expectations and deliverables.
- Plan, assign, and review work for QA team members and provide ongoing feedback and development opportunities.
- Facilitate team meetings and promote continuous communication and knowledge sharing within the team.
- Support recruitment, onboarding, and performance management of QA staff.
Preferred candidate profile
- Bachelors degree in Pharmacy, Life Sciences, or related field (Masters preferred).
- Extensive experience (typically 7+ years) in Pharmacovigilance with significant exposure to QA activities.
- Strong knowledge of global pharmacovigilance regulations, GVP, and quality management systems.
- Proven leadership and team management skills.
- Experience in conducting audits and managing CAPAs.
- Excellent communication, organizational, and problem-solving skills.
- Ability to work collaboratively with cross-functional teams and external vendors.
THANKS YOU
REGARDS
MILAP RATHOD
HR DEPARTMENT
OPES HEALTHCARE PRIVATE LIMITED
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