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HR at Biocon

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Biocon - Manager - Audit - Quality Process/GMP (9-10 yrs)

Bangalore Job Code: 860515

- Independently performs audit / evaluations of quality systems and practices, to identify potential problems such as Non-Conformance to applicable SOPs and Quality Standards (GMP, ISO, etc.).

- End to end responsible for coordination, query and coordinates resolutions, and should be able to provide guidance on quality/compliance risk levels in the report.

- The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports.

- Act as Subject Matter Expert for the Corporate Audit / Risk Management and Risk Investigations group, mentoring and providing guidance to other colleagues. Drive / contribute to the completion of complex reviews/audits and other Business Assurance projects and take responsibility for a portion of the teams milestones / deliverables.

- Prepares audit reports and communicates findings to external and internal stakeholders.

- Tracks audit responses and auditees CAPA until completion and closeout.

- Assisting / developing processes including development and implementation of continuous improvement techniques.

- The individual will be expected to develop collaborative relationships with the operations, laboratory, quality, and other supporting groups to facilitate investigations using continuous improvement techniques.

- Be able to use knowledge to investigate process deviations and typical results. Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards

- Ability to coordinate and facilitate meetings and lead conversations.

- Work under limited supervision, with the ability to problem solve, manage priorities, and make decisions independently.

Education / experience and skill sets:

- Senior position with 9 - 10 years of experience in areas of quality reviews / audit, including GMP audits etc.

- Minimum qualifications - BS or MS.

- The incumbent must be a collaborative team player with strong coordination, facilitation and writing Proficient project management and influencing skills in relation to investigation delivery PREFERRED QUALIFICATIONS Proficiency in deviation management system Experience with six sigma methodologies

- This position will report to the Global Head for Corporate Audit, Risk Management, and Investigation.

- Has extensive experience and technical expertise in areas of quality audits (including quality assurance and monitoring process) and GMP audit. Detailed understanding of the processes and systems involved in the manufacture of biopharmaceuticals.

- Thorough knowledge of current standards and regulations related to pharmaceutical procedures and devices, (e. g., GMP, GLP, and guidance documents)

- Demonstrates the ability to review investigations, change control, analytical data, test reports, batch records and certificates of analysis and other technical documents. Have a fundamental understanding of the investigation process as it applies to manufacturing and laboratory issues.

- Strong ability with MS Word, Excel, Power Point and Outlook.

- Good communication skills - written and verbal.

Women-friendly workplace:

Maternity and Paternity Benefits

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