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Vacancy for Manager in QA & RA Compliance at Abbott India

 

Clinical courses

Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.

Post : Manager QA & RA Compliance

Job description:
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world - in nutrition, diagnostics, medical devices and branded generic pharmaceuticals - that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.

  • Support in developing, implementing, assuring and monitoring the Quality and Regulatory Compliance strategies of the company.
  • Support evaluation of adequacy and compliance of systems, operations and practices against regulations and company documentation.
  • Closely work with Management Representative for India to provide updates on Quality and Compliance issues and also support in India Management Review Meetings with timely inputs
  • Support management of the complaint handling system and prepare analysis report for the management review
  • Support Field Safety Corrective Action / Recall, Corrective & Preventive Actions (CAPA)& Stop Shipment
  • Support Internal & External Quality & Compliance Audits
  • Support management of ATMS trainings and assign trainings to all new employees within 14 days of joining. Also monitor relevant trainings assigned to all employees with respect to their job functions in India
  • Create, review and approve all labelling for marketed products prior to use for assigned products/projects
  • Lead all label and relabeling activities/negotiations and executions.  Work with Labelling team to be compliant to India Specific labels as per local regulation
  • Review and approve advertising, promotional items and labelling for regulatory compliance
  • Tracks Quality issues through to closure including reviewing corrective action taken
  • Provide feedback on the new procedures (SOP or DOP) being developed by International quality & compliance team
  • Prepare and submit all PSURS, PMS reports, Adverse Event Reports and other safety reports to the regulators
  • Identify major regulatory and compliance risk and threats to the overall business in India and South Asia and update the management regarding the same.
  • Working cohesively with all functions at local and global level on requirements for Quality and Regulatory Compliance.
  • Develop and monitor programs to ensure compliance with related acts and regulations in conformance with industry standards.
  • Collaborate with senior management team to review and approve documentation provided by various functions including but not limited to working directly marketing, sales and supply chain.
  • Support Sales team with regards to any regulatory documents required for tender approval
  • Manage Product Release Approval (PRA) Release post approvals and India Specific labels are released
  • Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications
  • Identify the need for and provide input into development of systems for assigned projects for the efficient operation of the department
  • Provide input into development of regulatory and quality systems, SOPs for the efficient operation of the department and inter-department activities.
  • Provide training to the regulatory staff and Sales Reps and Distributors as needed
  • Regularly gets updated and self-trained with the latest regulations on Medical devices in the country
  • Networking and Liasioning with the Regulatory agencies both at centre and state level

 

Additional Information:
Location: New Delhi
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Keyword or Job ID:
30043505
Functional Area: QA & RA Compliance
End Date: 31st October, 2017

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