What are the responsibilities and job description for the Principle Quality Assurance Compliance Specialist position at Piramal Group?
Business: Critical Care
Department: Quality Assurance (Electronic System)
Location: Bethlehem
Job Overview
The purpose of this role is to define the roles and function for the Principal Quality Assurance Compliance Specialist Electronic Systems
Key Stakeholders: Internal
Corporate IT /QA, Site Management, All Departments
Key Stakeholders: External
FDA or other health organizations
Reporting Structure
Reports to QA Associate Director
Essential Duties and Responsibilities
- Ensure all the computerized systems meeting the 21 CFR Part 11, EU ANNEX 11and GAMP5 guidelines requirements.
- Perform, review & approve computerized system validation life cycle deliverables.
- Responsible for implementation and compliance of data integrity at site as DICO (Data Integrity Compliance officer).
- Implement regimen of Data integrity checks on shopfloor and updating of Data Integrity Risk Assessment (DIRA).
- Responsible for handling and compliance of SOPs related to Data Integrity & IT systems.
- Review / conduct of investigations related to Data integrity, Computerized Systems, and engineering department as applicable.
- Coordination for data integrity and IT-systems projects with stakeholders at site and corporate.
- Handling & Participation in internal & Data Integrity audits.
- Involve in selection of Data Integrity (DI) champions & impart necessary trainings to the DI champions.
- Review of Change controls, Deviations, CAPA and other QMS tools.
- Review of Periodic review reports.
- Participated in supplier assessment for Computerized Systems, instruments & equipment's etc.
- Review approve the schedules of data back-up & restoration, time synchronization etc.
- Audit trail reports review of computerized systems.
- Review and ensure the compliance of user management activities of Computerized Systems.
- Preparation / review of the quality risk assessments i.e. part 11 compliance, data integrity etc.
- Review the Qualification documents of the manufacturing equipment's, facility, utilities and associated ancillary systems.
- CAPA effectiveness verification.
- GMP compliance verification for the manufacturing equipment area, utilities and testing instruments.
- Review of software application qualifications.
- Comply with SHE Guidelines, SHE Rules and Regulations. Comply with usage of PPE wherever applicable.
- Observe noncompliant acts and conditions and take corrective & preventive actions immediately, as necessary.
- Report any incident/accident/near miss/illness to the superiors.
- Follow company's quality procedures, standards, and specifications.
- And any other job as may be assigned to you from time to time by HOD.
- Also responsible for the work of the senior, in absence of senior.
Key Competencies (knowledge, skills and abilities every person must possess to be successful)
- Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
- Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers.
- Excellent verbal and written communication skills.
- Creative and able to present various solutions.
- Energetic, enthusiastic and motivational disposition.
- Maintain confidentiality.
- Coaching skills.
Education / Experience
- Bachelor’s degree in relevant scientific quality assurance / technical field.
- 5 years of experience.
- Strong understanding of pharmaceutical cGMP, industry standards, and regulations.
- Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels.
- Expert level user for Quality computer systems, Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems.
- Thorough understanding of computer system validation and GAMP requirements.
- The ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports.
- The ability to drive projects in relation to implementation of new workflows and updates to new systems.
Department: Quality Assurance (Electronic System)
Location: Bethlehem
Job Overview
The purpose of this role is to define the roles and function for the Principal Quality Assurance Compliance Specialist Electronic Systems
Key Stakeholders: Internal
Corporate IT /QA, Site Management, All Departments
Key Stakeholders: External
FDA or other health organizations
Reporting Structure
Reports to QA Associate Director
Essential Duties and Responsibilities
- Ensure all the computerized systems meeting the 21 CFR Part 11, EU ANNEX 11and GAMP5 guidelines requirements.
- Perform, review & approve computerized system validation life cycle deliverables.
- Responsible for implementation and compliance of data integrity at site as DICO (Data Integrity Compliance officer).
- Implement regimen of Data integrity checks on shopfloor and updating of Data Integrity Risk Assessment (DIRA).
- Responsible for handling and compliance of SOPs related to Data Integrity & IT systems.
- Review / conduct of investigations related to Data integrity, Computerized Systems, and engineering department as applicable.
- Coordination for data integrity and IT-systems projects with stakeholders at site and corporate.
- Handling & Participation in internal & Data Integrity audits.
- Involve in selection of Data Integrity (DI) champions & impart necessary trainings to the DI champions.
- Review of Change controls, Deviations, CAPA and other QMS tools.
- Review of Periodic review reports.
- Participated in supplier assessment for Computerized Systems, instruments & equipment's etc.
- Review approve the schedules of data back-up & restoration, time synchronization etc.
- Audit trail reports review of computerized systems.
- Review and ensure the compliance of user management activities of Computerized Systems.
- Preparation / review of the quality risk assessments i.e. part 11 compliance, data integrity etc.
- Review the Qualification documents of the manufacturing equipment's, facility, utilities and associated ancillary systems.
- CAPA effectiveness verification.
- GMP compliance verification for the manufacturing equipment area, utilities and testing instruments.
- Review of software application qualifications.
- Comply with SHE Guidelines, SHE Rules and Regulations. Comply with usage of PPE wherever applicable.
- Observe noncompliant acts and conditions and take corrective & preventive actions immediately, as necessary.
- Report any incident/accident/near miss/illness to the superiors.
- Follow company's quality procedures, standards, and specifications.
- And any other job as may be assigned to you from time to time by HOD.
- Also responsible for the work of the senior, in absence of senior.
Key Competencies (knowledge, skills and abilities every person must possess to be successful)
- Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
- Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers.
- Excellent verbal and written communication skills.
- Creative and able to present various solutions.
- Energetic, enthusiastic and motivational disposition.
- Maintain confidentiality.
- Coaching skills.
Education / Experience
- Bachelor’s degree in relevant scientific quality assurance / technical field.
- 5 years of experience.
- Strong understanding of pharmaceutical cGMP, industry standards, and regulations.
- Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels.
- Expert level user for Quality computer systems, Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems.
- Thorough understanding of computer system validation and GAMP requirements.
- The ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports.
- The ability to drive projects in relation to implementation of new workflows and updates to new systems.
