Our client is one of the leading Pharma companies in India. Will get ranked in the top 10 in the country. They are looking for Head of Operations for Vizag .
- A candidate who is heading the Operations of a US FDA approved facility for the last 5 to 10 years
- He must be Msc / B.Tech-Chemical/BE -Chemical/Ph D-Will give some preferences)
Job Requirement :
- Proven experience in API Manufacturing, technology deployment, project management and plant utilization and productivity initiatives, team player with leadership skills
- Responsible for overall production and related operations.
- To ensure that all plant operations are carried out as per cGMP standards and meets the current regulatory requirement.
- To ensure that products are manufactured in accordance with laid down quality standards.
- To ensure that production records are duly completed and evaluated by authorized person.
- To evaluate proposed changes in product, process or equipment and ensure that appropriate validations are done.
- Assist in the investigation of batch failures, market complaints and product recalls, if any.
- To ensure that the required initial and continuous training of personal are carried out.
- To ensure that the calibration and maintenance are undertaken as per laid down standards.
- To co-ordinate with production planning department.
- To participate in vendor qualification process and also in vendor audits, wherever necessary.
- To ensure plant hygiene practices are followed by each employee.
- To ensure the Implementation of Environment, Health and Safety policy requirements in the plant.
- To review and approve all quality notifications like MNC, PNC, Exceptions and CAPA.
- To conduct self-inspection and to ensure adequate compliance/preventive actions are taken for the same.
- To participate in quality management reviews at specified intervals for Updation of critical quality attributes.
- To ensure proper risk assessments are done for each major change and approve the same.
- To ensure continuous up gradation of practices and systems to meet cGMP& regulatory requirements
Interested candidates may call S.Krishnan at 040 40141006
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