Symbiotec - Site Quality Head

Job Responsibility:

- To ensure preparation, review and approval of all procedures, in line with the regulatory guidelines/ expectations, identify the gaps and update the procedure.

- To handle the day today changes, deviations, incidents, market complaints, OOS, OOT are investigated in line with regulatory expectations in time bound fashion.

- To develop second line personnel's by training the operating level and supervisors /reporting authorities to evaluate and implement the risk and science-based approach in decision making.

- To coordinate with different functions like R&D, production, engineering, RA, purchase, compliance, marketing etc.

- To bring about a robust system to ensure that it meets the regulatory.

- Ensure that the analytical tech transfer is a well planned process and successful at the site.

- To conduct training for all technical staff, inculcate the culture of quality and compliance, and have the schedules adhered to as per the training calendar.

- To host the audits by customers and regulatory authorities.

- To provide regulatory / customer audit response in conjunction with corporate quality and deep track on the CAPA's for time bound closures.

- To be actively involved in all investigations related to the quality issues at the site, to help the marketing team and the customers get the required technical clarifications in a timely manner, etc.

- To identify, understand and evaluate the need for infrastructural requirements and to organize for the timely procurement of such requirements to improve the efficiency and effectiveness of the quality functions.

- To derive mechanism for measurement of productivity and achieve organizational goal of QA&QC.

- To ensure all marketing requests are responded to in a timely manner.

- To track and update closure of all quality notifications in a timely manner.

- To ensure quality trends of products are prepared and reviewed in timely.

- To ensure all regulatory queries related to analytical validation are responded to in a timely manner.

- To ensure all qualification and Validations are successfully carried out as per schedule.

- To ensure Annual Product Review is prepared and approved in a timely manner.

- To steer and participate Quality Management review of Level-1 and level-2 at site.

- To participate in Quality Management review level-3 and present it to the top Management.

- Preferable candidate should be from Biotech/ Pharmaceutical API industry only.