Symbiotec - Site Quality Head

Symbiotec Pharmalab Pvt. Ltd.

0 years

0 Lacs

Ujjain Madhya Pradesh India

Posted:4 weeks ago| Platform:

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Skills Required

training risk engineering compliance marketing audits audit procurement efficiency effectiveness measurement notifications management api

Work Mode

On-site

Job Type

Full Time

Job Description

Job 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.

(ref:iimjobs.com)

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