Head - Operations - Pharma API

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 Hyderabad .

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