Piramal - Manager - Quality - External Supply

Piramal - Manager - Quality - External Supply

JOB OVERVIEW :

- Ensure PCC External Product Suppliers are meeting their contracts in line with our core values & ethical practices.

- Ensure systems at all PCC sites for external suppliers are in synchronization with current regulations & customers expectations.

- Assure the quality of external supplier products and processes by establishing and enforcing quality standards.

Key Responsibilities :

- 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 (OTIF).

- 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 Companys Values Knowledge, Action, Care, Impact

- Ensure implementation of Companys 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.

Qualifications : Degree in Pharmacy or Organic Chemistry

EXPERIENCE :

- Quality professional with 10+ years of experience in regulated Pharma companies, with minimum 5 years in sterile formulations.

- 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.