Position : Assistant Manager - Q&A

Qualification : B.Pharma

Job Description :

- Coordinate and schedule supplier and service provider audits in accordance with GQP and current GMPs. Lead and conduct supplier audits, issue audit reports, follow-up on responses CAPAs and close out supplier audits.

- Perform Due Diligence visits/audits of potential new suppliers to company, produce reports and provide recommendations regarding suitability and compliance of new suppliers.

- Propose any follow-up remediation or CAPAs relevant to the new supplier.

- Responsible for suggesting/evaluating changes to the audit system, making changes to the system, working with departments within and outside QA to improve quality as related to the system, producing reports as required, and training personnel on the system.

- To ensure timely input of data into the Audit System.

- Develop and maintain effective relationships with external suppliers, contractors, and business partners as well as company Site QA and other internal departments in order to ensure timely audits, communication, and resolutions to discovered deficiencies and/or concerns.

- Make decisions and provides recommendations to senior management that have direct impact on site and supplier quality and subsequent commercial manufacturing operations and/or product supply.

- Take appropriate actions to ensure any remediation are implemented.

- Provide technical and regulatory guidance to internal and external stakeholders to ensure overall quality and compliance.

- Works with the management to ensure the continuous compliance, development and improvement of company and vendor audit programs.

- Provide information/insight on regulatory requirements and stay abreast of changes in regulatory environment/trends.

- Identifies root cause to complex and/or broader problems 

- Develops solutions and implements action plans to mitigate risks, informing and escalating as required.

- Provide expert inspection and logistics support during inspections of sites by regulatory agencies and customers.

- Follow up and compile information to support response and commitments made in the response to inspection reports.

- Conduct quality based training programs at contract sites.

- Provide QA support projects like Technology transfer and new product launches by performing gap analysis.

Skills : 

- Excellent working knowledge of ISO/GMP/QMS.

- Good knowledge of computer and MS Office.

Experience : Minimum 5-10 yrs of experience across all areas of production with exclusive experience of 3 yrs in QA.

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