What are the responsibilities and job description for the Compliance Specialist position at Piramal Group?
Business: Pharma Solutions
Department: Quality Assurance
Location: Lexington
Job Overview
The Compliance Specialist ensures compliance with global regulatory requirements governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products at Piramal Pharma Solutions, Inc. - Lexington. This position will support overall cGMP and regulatory compliance at the site by ensuring that the quality systems are used effectively to support company quality policy and objectives.
Reporting Structure
Section Director, Quality & Regulatory Compliance
Key Responsibilities
- Provide support and coordination for compliance-related projects
- Act as a primary point of contact for Supplier Quality Management
- Oversee review of corporate quality assessments of FDA observations (483s, Warning Letters) for their applicability to PPS-Lexington processes and procedures
- Develop and maintain quality system performance metrics for site and corporate management
- Provide support and documentation as necessary for client regulatory filings, annual product review activities, and health authority inspection responses
- Interact with clients and internal customers regarding compliance issues
- Create, prepare and review technical reports
- Act as the PPS-Lexington Data Integrity Coordinator
- Support site Quality Management Review process and reporting
- Apply cGMP (Current Good Manufacturing Practice) concepts into quality system documentation review, and development and/or modification of quality systems and other cGMP processes.
- Act as backup Change Control System / Process owner, including metrics, review/approval, and oversight activities
- Act as CAPA System / Process owner, including metrics, review/approval, and oversight activities
- Act as backup EVR System / process owner, including metrics, review/approval, and oversight activities
- Other duties as required by organizational needs
Education
- Bachelor’s degree in a scientific discipline or equivalent
Experience
- 4 years of QA, Quality Systems, and/or Compliance experience in a cGMP/FDA regulated environment
- Sterile manufacturing of injectibles preferred
- Experience as a system / process owner for Quality Systems, including development and maintenance of performance metrics and internal customer support preferred
Functional and Technical Skills
- Working knowledge of cGMP regulations, guidance, and general compliance expectations.
- Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writing.
- Must be a detail oriented team player with effective planning, analytical thinking, organization, and execution skills
- Must have basic proficiency in the Microsoft Office Suite, with moderate expertise in Excel
- Excellent communication skills with internal and external personnel is essential.
- Ability to work effectively at a fast pace with cross-functional departments and manage priorities to meet timelines
- Must be Innovative, proactive, resourceful and committed to continuous improvement
- Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred
Department: Quality Assurance
Location: Lexington
Job Overview
The Compliance Specialist ensures compliance with global regulatory requirements governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products at Piramal Pharma Solutions, Inc. - Lexington. This position will support overall cGMP and regulatory compliance at the site by ensuring that the quality systems are used effectively to support company quality policy and objectives.
Reporting Structure
Section Director, Quality & Regulatory Compliance
Key Responsibilities
- Provide support and coordination for compliance-related projects
- Act as a primary point of contact for Supplier Quality Management
- Oversee review of corporate quality assessments of FDA observations (483s, Warning Letters) for their applicability to PPS-Lexington processes and procedures
- Develop and maintain quality system performance metrics for site and corporate management
- Provide support and documentation as necessary for client regulatory filings, annual product review activities, and health authority inspection responses
- Interact with clients and internal customers regarding compliance issues
- Create, prepare and review technical reports
- Act as the PPS-Lexington Data Integrity Coordinator
- Support site Quality Management Review process and reporting
- Apply cGMP (Current Good Manufacturing Practice) concepts into quality system documentation review, and development and/or modification of quality systems and other cGMP processes.
- Act as backup Change Control System / Process owner, including metrics, review/approval, and oversight activities
- Act as CAPA System / Process owner, including metrics, review/approval, and oversight activities
- Act as backup EVR System / process owner, including metrics, review/approval, and oversight activities
- Other duties as required by organizational needs
Education
- Bachelor’s degree in a scientific discipline or equivalent
Experience
- 4 years of QA, Quality Systems, and/or Compliance experience in a cGMP/FDA regulated environment
- Sterile manufacturing of injectibles preferred
- Experience as a system / process owner for Quality Systems, including development and maintenance of performance metrics and internal customer support preferred
Functional and Technical Skills
- Working knowledge of cGMP regulations, guidance, and general compliance expectations.
- Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writing.
- Must be a detail oriented team player with effective planning, analytical thinking, organization, and execution skills
- Must have basic proficiency in the Microsoft Office Suite, with moderate expertise in Excel
- Excellent communication skills with internal and external personnel is essential.
- Ability to work effectively at a fast pace with cross-functional departments and manage priorities to meet timelines
- Must be Innovative, proactive, resourceful and committed to continuous improvement
- Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred
