Macleods Pharma Pharmacovigilance jobs: PV QA role
PV QA Role at Macleods Pharma LTD
Are you an experienced professional in the field of Pharmacovigilance with a strong background in Quality Assurance (QA)? Macleods Pharma LTD is offering an exciting opportunity for a PV QA role that requires 5 to 10 years of experience. As an individual contributor, you’ll play a pivotal role in ensuring the highest standards of compliance, quality, and process improvement within our Pharmacovigilance operations.
The Role: Key Responsibilities
As a PV QA professional, your role will encompass a range of critical responsibilities to ensure the effective functioning of our Pharmacovigilance operations:
- Regulatory Compliance: Utilize your extensive knowledge of regulatory guidelines to perform audits and verify compliance with not only industry standards but also Macleods Pharma LTD’s specific requirements.
- Audit Planning: Develop comprehensive audit plans and execute audits for studies, processes, systems, and facilities, making sure they adhere to regulatory guidelines and Standard Operating Procedures.
- Global Policies Implementation: Contribute to the establishment of Pharmacovigilance (PV) quality management processes that align with both global policies and local regulations.
- Quality Improvement: Play an integral part in initiatives aimed at enhancing quality, streamlining processes, and boosting compliance within Pharmacovigilance operations.
- Pharmacovigilance System Audits: Conduct audits related to Pharmacovigilance systems for both post-marketed and clinical development products. Prepare detailed reports outlining audit findings and communicate them to relevant stakeholders.
- Corrective Action: Oversee the implementation of corrective actions based on audit reports and ensure timely closure of these reports.
- System Process Audits: Extend your audit expertise beyond the organization by conducting audits of subsidiaries, vendors, distributors, and partners, providing valuable insights for improvement.
- Regulatory Inspection Preparation: Collaborate with the Pharmacovigilance team to prepare for regulatory inspections, ensuring that all processes and procedures are aligned with regulatory requirements.
- QMS Support: Offer Quality Management System (QMS) support to the Pharmacovigilance team, reinforcing quality standards and adherence to protocols.
How to Apply
If you’re ready to take on this challenging yet rewarding role, we encourage you to apply. Here are the details you need to know:
- Experience Required: 5 to 10 years of experience in Pharmacovigilance operations with a strong emphasis on Quality Assurance.
- Role Type: Individual contributor
- Contact Email: Send your application to [email protected]
