Assoc Manager, QA.Quality.Quality Assurance
GENERAL SUMMARY OF POSITION
Overall handling of quality management system as per the requirements of ISO13485, ISO 9001.
In-charge of Microbiology Laboratory and incoming/in-process/final release inspection laboratories
RESPONSIBILITIES & SPECIFIC ACCOUNTABILITIES
Document control and record control in the plant
Overall responsibility of managing SOPs
Ensuring adequacy of records use in the plant
Conducting IQA as per the pre specified frequencies
Initiate CAPA projects for the issues arise time to time and monitor the effectiveness of the corrective actions
Issue NCMRs for the product / materials which are non-conforming
Overall responsibility of microbiology tests
Carryout incoming inspection for all receiving materials
Carryout inprocess inspection
Carryout Final release inspection and ensuring the quality of outgoing product
Handling of customer complaints (receiving/investigating/responding) and follow up the effectiveness of corrective actions.
Monitor the changes on packaging materials on Ansell Web Center (AWC).
Conducting Management Review in a predefined frequency
Collaborate with operations team during the changes are done. Initiation of CRI (according to the change control procedure) conducting risk assessment, validation, training changing SOPs
Train the team on Quality Management Systems.
KEY POSITION REQUIREMENTS
Degree in Microbiology
Diploma in Quality Management
Internal Quality Auditor Training
Job Experience :
At least 3 – 5 year experience in Quality
Knowledge and Skills :
High degree of computer literacy
Data analysis and report preparation
Preparation of presentation slides
Desirable Job Competencies:
Ability of interact with internal and external customers at all levels to develop relationship.
Good knowledge of the quality management systems
Good interpersonal and presentation skills.
Good knowledge in microbiology tests.
Additional Requirements (travel, etc.)
Be prepared to travel to local establishments and other Ansell locations as required by the company on business and job related matters.
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