Chief Manager - Corporate Quality Compliance Job in Piramal Enterprises Ltd.
Chief Manager - Corporate Quality Compliance
Piramal Enterprises Ltd.
4+ weeks ago
- Mumbai, Maharashtra
- Not Disclosed
- Full-time
- Permanent
Job Summary
Tounderstand the business & product needs with respect to systemestablishment and sustainability. In the process, it requires interactions withsite functions and also assessing complexities of current processes.
Ensurethat the customer (internal and external) needs are understood properly and theservices / products are delivered on time in full, from quality functionperspective.
Lead,participate in or facilitate for site visits or audits conducted by clients orregulatory / accrediting agencies.
Planand execute Internal Audit Plan at Corporate. Ensure audits are conducted asper plan, issue reports in a timely manner and monitor the associated CAPAs toaddress the audit observations.
Responseto regulatory queries and deficiencies.
PerformForensic auditing / Data Integrity Audits / Routine GMP audits to ensure thatthe Company maintains a state of readiness for inspection by regulatoryagencies.
Keepabreast of changes to quality regulations and guidelines, advising themanagement team of any business implications of these changes. Lead, manage andensure proper training to any relevant change management programs throughoutthe site / company.
Improvequality compliance by recommending and following-up on improvement plans,training and contributing information to cross-functional quality improvementteams.
Developeffective partnerships with internal staff and external organizations tofacilitate problem solving and resolution of issues.
Preparequality assurance reports by collecting, analyzing, and summarizing data andtrends.
Preparerisk papers, position papers, conduct root cause analysis, propose andimplement CAPA and risk mitigation plans for quality, compliance, existingbusiness sustenance and business continuity.
Providemonthly KPIs and status reports on compliance initiatives to management.
Coordinatewith Site and Corporate team for Corporate Initiatives, improvising Long TermQuality Strategy.
EffectiveAberration Handling (Review and Approval): Lead investigations for a variety ofnon-conformances which may include deviations, OOT, OOS, Batch Failure,Rejections. Identify appropriate SMEs, gather information/data, prepareinvestigation reports, and shape corrective/preventive actions to resolverecurring problems with permanent solutions.
Ensuremarket complaint investigation and recalls are executed by site team thoroughlyand timely. Facilitate the process and ensure compliance to procedures andassociated metrics.
Qualification :
Atleast 5 yearsin dosage forms preferably injectable or Oral Solid Dosage
Well-organizedand detailed oriented professional, with strong verbal and writtencommunication skills, as well as should have experience of technical writing
Handson experience implementing quality systems in a GxP environment, and directexperience with FDA, MHRA and other health authority inspections
Extensiveknowledge of US GxP compliance regulations and industry practices, as well asEU GMP requirements
Strongtechnical understanding with ability to analyze & report complex information
Strongin problem solving with superior investigation and interview skills
Description
Establishand deploy a quality compliance program; collaborate with key QA/RAstakeholders enterprise-wide to implement a standardized quality system builtupon best practices from internal sites and outside industry standards.Tounderstand the business & product needs with respect to systemestablishment and sustainability. In the process, it requires interactions withsite functions and also assessing complexities of current processes.
Ensurethat the customer (internal and external) needs are understood properly and theservices / products are delivered on time in full, from quality functionperspective.
Lead,participate in or facilitate for site visits or audits conducted by clients orregulatory / accrediting agencies.
Planand execute Internal Audit Plan at Corporate. Ensure audits are conducted asper plan, issue reports in a timely manner and monitor the associated CAPAs toaddress the audit observations.
Responseto regulatory queries and deficiencies.
PerformForensic auditing / Data Integrity Audits / Routine GMP audits to ensure thatthe Company maintains a state of readiness for inspection by regulatoryagencies.
Keepabreast of changes to quality regulations and guidelines, advising themanagement team of any business implications of these changes. Lead, manage andensure proper training to any relevant change management programs throughoutthe site / company.
Improvequality compliance by recommending and following-up on improvement plans,training and contributing information to cross-functional quality improvementteams.
Developeffective partnerships with internal staff and external organizations tofacilitate problem solving and resolution of issues.
Preparequality assurance reports by collecting, analyzing, and summarizing data andtrends.
Preparerisk papers, position papers, conduct root cause analysis, propose andimplement CAPA and risk mitigation plans for quality, compliance, existingbusiness sustenance and business continuity.
Providemonthly KPIs and status reports on compliance initiatives to management.
Coordinatewith Site and Corporate team for Corporate Initiatives, improvising Long TermQuality Strategy.
EffectiveAberration Handling (Review and Approval): Lead investigations for a variety ofnon-conformances which may include deviations, OOT, OOS, Batch Failure,Rejections. Identify appropriate SMEs, gather information/data, prepareinvestigation reports, and shape corrective/preventive actions to resolverecurring problems with permanent solutions.
Ensuremarket complaint investigation and recalls are executed by site team thoroughlyand timely. Facilitate the process and ensure compliance to procedures andassociated metrics.
Qualification :
Qualifications
QUALIFICATION:
Degree (advanced degree preferred) in Pharmacy
EXPERIENCE:
Qualityprofessional with 15+ years of experience in a regulated pharma companiesAtleast 5 yearsin dosage forms preferably injectable or Oral Solid Dosage
Well-organizedand detailed oriented professional, with strong verbal and writtencommunication skills, as well as should have experience of technical writing
Handson experience implementing quality systems in a GxP environment, and directexperience with FDA, MHRA and other health authority inspections
Extensiveknowledge of US GxP compliance regulations and industry practices, as well asEU GMP requirements
Strongtechnical understanding with ability to analyze & report complex information
Strongin problem solving with superior investigation and interview skills
Experience Required :
Fresher
Vacancy :
2 - 4 Hires
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