Quality Assurance-GOA

Product : personal care/ hygiene / health care products/ feminine care, baby hygiene.

Position : Quality Assurance

Education: Bsc, Msc (Chemistry)/ B.pharm/M.pharm

Experience : 2 to 5 years- of- experience in the Quality Assurance function in the FMCG / Pharma- industry,- personal care/ hygiene Products,- toiletries.- good in documentation, Corrective and Preventive Actions.(COPA)

Required Skills :

- Familiarity with production process, Quality assurance system- in FMCG / Pharma- industry, especially- personal care/ hygiene Products- toiletries.

- Analytical skills

- Process orientation

- Creativity & Innovation

Gender : Male only

Working : Two Shifts

Roles & Responsibilities :

- Perform and lead validation activities related to Product at site

- Preparation /change and validation of BOM

- Investigation of product complaints

- Ensure that processes /procedure needed for the Quality Management System (QMS) are established, implemented and maintained.

- Report to performance of the QMS and any need for improvement.

- Coordinate with other Dept.'s and ensure the promotion of awareness of customer requirements throughout the organization

- Ensure that a document control procedure review and update all changes to critical documents of the QMS.

- Ensure that records are established are maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records.

- Ensure that the performance of the QMS is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness.

- This review means assessing opportunities for improvement and the need for changes to the QMS.

- Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. 

- Provide update training as necessary.

- Ensure that undertakes periodic but regular assessments of customer satisfaction and that consequent improvements are identified and implemented.

- Ensure that an internal audit programme is adopted to verify that the QMS conforms to planned arrangements, QMS arrangements and is effectively implemented and maintained.

- Analyse data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.

- Co-ordinate continual improvements of the QMS, ensuring that evidence of corrective and preventive actions taken are recorded and reviewed

- Carry out product compliant analysis- Complaint Analysis, Root cause analysis, Initiation of CAPA and reporting

- Initiate and ensure that CAPA initiated for deviations and ensure that CAPA process as per SOP completed on time

- Carry out in process checks, Product defect analysis & report improvement action Plan monthly basis

- Data collection and report monthly Quality KPI's based on parameters identified.

- Ensure implementation of change control process for any critical changes which effect QMS

- Prepare protocol, plan and carry out validation as per DQ, IQ, OQ, PQ protocol for any new machinery, process change, Product spec change etc.

- Provide QMS &GMP Class Room /OPL Training to whom so ever relevant to QMS (like Production, Stores, Purchase, Distribution, QC/QA officers )

- Carry out BMR issue, review and control. Carry out improvement in BMR needed in coordination with effected Dept.'s like production, Stores, Distribution, QC Dept.