QPI Expert (Quality + Pharmacovigilance)

Groupe ProductLife; India; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Groupe ProductLife is seeking a QPI Expert (Quality + Pharmacovigilance) in India. The role focuses on developing and maintaining the quality management system, ensuring compliance with ICH, GCP and local regulations. Occasional travel for audits and training is expected.

The candidate should have 8+ years in quality within the pharmaceutical industry and prior PV domain knowledge. Collaboration with leadership to drive continuous process improvements is essential.

Qualifications

• Bachelor’s or higher degree in a science related field or equivalent experience.
• 8+ years of experience in a Quality role in the pharmaceutical industry with PV knowledge.

Responsibilities

• Support development, implementation and maintenance of the corporate quality system.
• Develop and maintain the ProductLife Group quality management system and ISO 9001 alignment.
• Manage internal and client audits and inspection findings; act as key contact for auditors and vendors.
• Oversee training programmes and ensure quality deliverables meet SOPs and regulatory guidelines.
• Provide quality verification and corrective action plans for non-conformities.

Skills

Client relationship

Autonomy

Proactivity

Education

Bachelor's or higher in science

Job description

QPI Expert (Quality + Pharmacovigilance)

India

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Other

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Specific activities and responsibilities:

• Collaboration with Head of Quality and Process Improvement to support ongoing development, implementation and maintenance of the corporate quality system.
• Develop and maintain the ProductLife Group quality management system, including requirement for obtaining ISO 9001 certification, with ongoing alignment with the corporate quality management system
• Recommend, develop and maintain the controlled document system, including SOPs, WPDs and any associated forms and templates.
• Ensure data in Quality trackers / system are accurate, up to date and entered in a timely manner, to enable automated reporting.
• Identify process efficiency/effectiveness issues and provide solutions for improvement.
• Maintain a strong working knowledge of SOPs as well as ICH, GCP, local regulations and guidelines.
• Provide quality verification and oversight including corrective action plans for activities not meeting quality standards.
• Provide interpretation and relay to the Managers the need for continuous improvement of processes.
• Management and implementation of ProductLife Group annual risk based audit program (occasional travel)
• Management of internal and client audit and inspection findings.
• Act as the key point of contact for client auditors and vendors PLG audits.
• Support and maintain quality activities for oversight of vendors, suppliers and subcontractors to ensure they are functioning appropriately and audit as required.
• Oversee, maintain and improve training programs within ProductLife Group.
• Work with the departments to develop guidelines and metrics to assure quality and compliant deliverables.
• Quality representative at Global Quality Management Team meetings (occasional travel).
• Collaborate effectively with other managers.

Required education:

Bachelor’s or higher graduate degree in a science related field, or
equivalent experience

Required experience :

8 + years’ experience within a Quality role in Pharmaceutical
industry + previous role or knowledge in PV domain.

Additional experience and/or skills:

Client relationship
Autonomy
proactivty

QPI Expert (Quality + Pharmacovigilance)