Team Lead

2 days ago

Ahmedabad, Gujarat, India Opes Healthcare Full time ₹ 1,04,000 - ₹ 1,30,878 per year

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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