Piramal Pharma Quality Job Opening – Manager Post
Piramal Pharma Vacancy Piramal Pharma. Piramal Ltd invites postgraduate and undergraduate Pharma candidates for the post of Manager- Quality. Interested and eligible candidates may apply online. Check out all the details on Rasayanika.com
Job Title: Quality Manager, External Supply
Location: Mumbai
Required Candidate profile
- Quality professional with 5+ years of experience in regulated pharma companies that use contract manufacturers
- Hands on experience of quality systems in a GxP environment, and direct experience with FDA, MHRA and other health authority inspections..
- Well-organized and detailed oriented professional, with strong verbal and written communication skills.
Job Description
- Apply the quality standards for external supply in line with the requirements of other members of PCC management.
- Ensure that the customer (internal and external) needs are properly understood and the services / products are delivered on-time and in-full.
- Maintain product quality by enforcing quality assurance policies and procedures and current regulatory requirements.
- Assist to achieve financial objectives by compliance to the quality assurance budget; scheduling expenditures; analyzing variances; initiating corrective actions.
- Collaborating with other members of management to bring to the market new products, undertake new projects and apply modifications to existing projects.
- Overall monitoring of quality activities at the sites allocated.
- Implementation and ongoing tracking of Quality Metrics for External Suppliers.
- Ensure adherence to Company’s Values – Knowledge, Action, Care, Impact
- Ensure implementation of Company’s Quality policy, Quality Management System (QMS), SOPs and GMP Regulations at concerned sites.
- Successfully Handling of Regulatory Inspections and Customer Audits / Visits.
- Response to regulatory queries and deficiencies.
- Review and resolution of customer queries / complaints.
- Prepare risk papers, position papers, conduct root cause analysis, propose and implement CAPA and risk mitigation plans for external supplier quality and compliance to sustain the existing business and to ensure business continuity.
- Effective Aberration Handling (Review and Approval): Out of Specification, Out of Trends. Deviation, Batch failure, Rejections.
- Review and approve quality documentation including Quality Agreements.
- Perform routine and for-cause inspections for GMP/GDP at warehouses, manufacturing and logistic areas.
- Compliance with applicable safety and environmental standards.
- Take relevant measures to avoid Cost of Poor Quality and control / reduce Cost of Conformance.
- Provide KPIs and status reports on projects and compliance initiatives to management.
Work across all disciplines (e.g. manufacturing, warehouse, engineering, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies. - 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.
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