Sr. executive – QA – Abbott Jhagadia Gujarat

About the Job – Sr. executive – QA – Abbott Jhagadia Gujarat

Primary Function/Primary Goals/Objectives:

To sustain Quality compliance at TPM, Complaint management for Plant

Describe the primary goals, objectives or functions or outputs of this position.

Major Responsibilities: 

1. TPM

• Finished product quality release for TPM locations
• Develop SOP’s for TPM to determine quality expectations.
• Review of quality performance of DHL on basis of set KPI’s and monthly reports
• Support DHL for continuous improvement with respect to quality performance
• Support DHL for quality incident investigations, development of CAPA, market complaint investigations.
• Support and timely review of Abbott defined systems for DHL site like Change controls systems, Deviations, Pest management and monthly trends, Internal audits schedule & its action closures, Temperature monitoring trends
• Support packaging design trials for DHL as per Protocol from packaging SME
• Working closely with Plant Manufacturing, R&D and Materials team to prepared/update PPS
• Sound knowledge on FSSAI and Legal metrology Act, Rules and regulation
• SAP knowledge on Quality module
• Responsible for ensuring that QA function compliance are in line with FSSAI, ISO 22000 requirement.
• Responsible for effective and effcient monitoring of site wide compliances, provides timely MIS, to ensure that all internal and external requirement are adhered.
• Perform ongoing gap analysis for corporate policies, site policies, sop’s and regulatory requirements applicable to site and develop action plan to close the gap and mitigate risk.
• Responsible for site Records Management Systems ensuring retention and retrival procedures are in place.
• Participate and contribute for internal and external audit schedules and follow up on action plan.
• Clear understanding of Quality Risk Management and priortise activities based on risk assessment of process equipment, utilities, facilities.
• To ensure a level of ‘governance’ is in palce with respect to all vendors associated with site to deliver compliance.
• Ensure GMP & Food Safety compliance as per FSSC 22000 & FSSAI requirement at DHL site.
• Prepare proper documents for Export products for different country as per their regulation.
• Before export ensure finished products are meet respective country regulation.
• Develop and ensure that required quality system related documents are in place and in use for New Product Introductions for timely execution.
• Oversee consumer complaint management and on-time escalation for any deviations, abnormalities.

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