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.