Piramal Pharma Hiring For Technical Support (QC)

Piramal Pharma Hiring For Technical Support (QC)

Position: Manager - Technical Support (QC)

Qualification: B. Pharm / M. Pharm

Location: Mumbai, Maharashtra, India

Business: Piramal Pharma Limited 

Department: Quality 

Travel: High

JOB OVERVIEW:

This position has responsibility for implementation / remediation of the systems, procedures and practices at the identified site(s) from a quality and compliance perspective.

KEY STAKEHOLDERS: INTERNAL – Site Quality Team, Site Head, Business Head, Corporate Functions

KEY STAKEHOLDERS: EXTERNAL – Customers, Regulatory Auditors

REPORTING STRUCTURE: Lead Technical Support and Quality Excellence

EXPERIENCE:

•Need to be ready to live and embrace the Piramal values.

•Quality professional with 10+ years of experience in regulated pharma companies. 

•Experience in API and Formulations. International Exposure.

•Worked in USFDA, MHRA approved facility. Faced regulatory inspections.

•Shall have good knowledge of QC Laboratory operations.

•Hands on experience implementing quality systems at site.

•Well-organized, committed and result oriented professional, with strong verbal and written communication skills. Good Collaboration skills and Team player.

•Passport is required.

•Candidates with valid US Visa preferred.

 

 KEY ROLES/ RESPONSIBILITIES:

To understand the business & product needs with respect to system establishment and sustainability. In the process, it requires interactions with different sites and also

assessing complexities of current processes.

Deputation at manufacturing sites as QC team member.

Perform site QC routine activities, Validation Activities, Internal audit / gap assessment as per FDA 6 system and DI (Data Integrity).

Lead remediation plan and restore compliance metrics at site.

Prepare risk papers, position papers, conduct root cause analysis, propose and implement CAPA and risk mitigation plans for quality, compliance, existing business

sustenance and business continuity.

Work across all disciplines to ensure that the site maintains a state of readiness for inspection by regulatory agencies.

Effectively track actions identified for restoring compliance at identified sites. Resolve the red flags and raise alerts timely.

Identify quality requirements by reviewing regulations, guidelines, and standards, including USFDA, EU GMP, ICH and ISO. Keep abreast of changes to quality regulations

and guidelines, advising the management team of any business implications of these changes. Lead, manage and ensure proper training to any relevant change

management programs throughout the site / company.

Represent Quality at senior management and review meetings.

Responsible to follow the safety and environmental procedures deployed at Kurla office and sites.

Coordinate with Corporate team for Corporate Initiatives and Long-Term Quality Strategy.

 

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