Piramal Group
Data Integrity and eCompliance Specialist
Piramal Group, Bethlehem, Pennsylvania, United States, 18020
Job Description
To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:
Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, ICH and related safety, health and environmental procedures, policies and practices. Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values. Identify and protect the original technical information as part of the company property. Responsibilities
Key responsibilities.
Data Integrity Compliance Officer (DICO), lead gap assessments of new and existing systems/practices; perform DI risk assessments for identified gaps; perform DI Audits of site; provide timely update on DI plan to Central DICO; and ensure site team is trained on DI aspects and requirements. To define validation strategy
and review CSV deliverables
for Site IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. for applications installed at Riverview Site. To define equipment/facilities qualification strategy
and review Validation Department deliverables
for Site equipment/facilities qualification e.g. URS, FRS, IQ, OQ, PQ, Risk assessment, drawings etc. for equipment/facilities at Riverview Site. To have thorough understanding, practical approaches for Computer system validation (CSV) of applications. Author, review and approval of SOPs, Guidelines/Policies as applicable to CSV, DI and equipment/facilities qualification. To perform periodic and audit trail review of computerized systems as per defined frequency. To support the initiatives undertaken by Corporate Quality eCompliance team in Riverview Site. Ability to represent during regulatory audits. Accountable to ensure compliance of CSV documentation and qualification during various phases (project, operational & retirement) of software lifecycle (SLC) and equipment/facilities. Well aware with GAMP5, CFR Part 11/EU Annex 11, Data integrity and ICH Q7 requirements. To ensure infrastructure (Network, Servers, Cloud, Database)and equipment/facilities are qualified as per required Quality standards and required documents are in place. To review QMS documents e.g. Change control/Deviation/Incidents-Discrepancy/User access forms To review and approve Root cause analysis and CAPA based on QMS documents. To guide and train Site IT & Business teams at Site for CSV, Data Integrity and Regulatory Compliance activities. To work along with CSV, Engineering & Project Manager to ensure project timelines are met. Review, approve and ensure compliance of the implementation, maintenance, and update of existing drawings from as-designed to as-built as appropriate for equipment/facilities. Ensure compliance and review/approve of site Validation Master Plan to include all GMP systems used at the site, including schedules for periodic review and as required, equipment/system requalification. Guide and mentor site teams on compliance of IT and electronic systems. Stay up to date on advances in the software and technology; provide appropriate training to new and current employees as needed. job conditions.
The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical Demands :
Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected. Long periods of standing and walking can be expected in this position. This position may require long periods of sitting, typing, computer entry or looking at a computer.
Work Environment :
Piramal Critical Care is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PCC staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes. Potential limited exposure to hazardous chemicals. Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.
Qualifications
EDUCATION/EXPERIENCE.
Bachelor's degree in Chemistry or life sciences. A minor in computer sciences is desirable. More than five (5) years of relevant experience. job competencies.
Excellent written and oral communication. Present and train relevant information to all levels within the company. Ability to adapt to and thrive in a dynamic work environment and cooperate with employees and clients from a broad range of disciplines and subject-level expertise. Demonstrated ability to multi-task on ongoing projects and tasks. To have in depth understanding of regulatory requirements and guidelines required to comply IT systems in Pharma industry - DI, Part 11, Annex 11, GAMP 5 etc. Knowledge of Pharma domain - Manufacturing and Quality (QA, QC) Experience of working on Pharma Manufacturing Site and functional knowledge about chromatography systems, SCADA, DCS etc. Understanding and exposure to Pharma CSV upcoming trends. Knowledge about Good documentation practices, DI and ALCOA+ Knowledge and experience on handling of QMS e.g. Change control, deviation and incidents. Knowledge and experience in equipment/facilities qualification
To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:
Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, ICH and related safety, health and environmental procedures, policies and practices. Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values. Identify and protect the original technical information as part of the company property. Responsibilities
Key responsibilities.
Data Integrity Compliance Officer (DICO), lead gap assessments of new and existing systems/practices; perform DI risk assessments for identified gaps; perform DI Audits of site; provide timely update on DI plan to Central DICO; and ensure site team is trained on DI aspects and requirements. To define validation strategy
and review CSV deliverables
for Site IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. for applications installed at Riverview Site. To define equipment/facilities qualification strategy
and review Validation Department deliverables
for Site equipment/facilities qualification e.g. URS, FRS, IQ, OQ, PQ, Risk assessment, drawings etc. for equipment/facilities at Riverview Site. To have thorough understanding, practical approaches for Computer system validation (CSV) of applications. Author, review and approval of SOPs, Guidelines/Policies as applicable to CSV, DI and equipment/facilities qualification. To perform periodic and audit trail review of computerized systems as per defined frequency. To support the initiatives undertaken by Corporate Quality eCompliance team in Riverview Site. Ability to represent during regulatory audits. Accountable to ensure compliance of CSV documentation and qualification during various phases (project, operational & retirement) of software lifecycle (SLC) and equipment/facilities. Well aware with GAMP5, CFR Part 11/EU Annex 11, Data integrity and ICH Q7 requirements. To ensure infrastructure (Network, Servers, Cloud, Database)and equipment/facilities are qualified as per required Quality standards and required documents are in place. To review QMS documents e.g. Change control/Deviation/Incidents-Discrepancy/User access forms To review and approve Root cause analysis and CAPA based on QMS documents. To guide and train Site IT & Business teams at Site for CSV, Data Integrity and Regulatory Compliance activities. To work along with CSV, Engineering & Project Manager to ensure project timelines are met. Review, approve and ensure compliance of the implementation, maintenance, and update of existing drawings from as-designed to as-built as appropriate for equipment/facilities. Ensure compliance and review/approve of site Validation Master Plan to include all GMP systems used at the site, including schedules for periodic review and as required, equipment/system requalification. Guide and mentor site teams on compliance of IT and electronic systems. Stay up to date on advances in the software and technology; provide appropriate training to new and current employees as needed. job conditions.
The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical Demands :
Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected. Long periods of standing and walking can be expected in this position. This position may require long periods of sitting, typing, computer entry or looking at a computer.
Work Environment :
Piramal Critical Care is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PCC staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes. Potential limited exposure to hazardous chemicals. Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.
Qualifications
EDUCATION/EXPERIENCE.
Bachelor's degree in Chemistry or life sciences. A minor in computer sciences is desirable. More than five (5) years of relevant experience. job competencies.
Excellent written and oral communication. Present and train relevant information to all levels within the company. Ability to adapt to and thrive in a dynamic work environment and cooperate with employees and clients from a broad range of disciplines and subject-level expertise. Demonstrated ability to multi-task on ongoing projects and tasks. To have in depth understanding of regulatory requirements and guidelines required to comply IT systems in Pharma industry - DI, Part 11, Annex 11, GAMP 5 etc. Knowledge of Pharma domain - Manufacturing and Quality (QA, QC) Experience of working on Pharma Manufacturing Site and functional knowledge about chromatography systems, SCADA, DCS etc. Understanding and exposure to Pharma CSV upcoming trends. Knowledge about Good documentation practices, DI and ALCOA+ Knowledge and experience on handling of QMS e.g. Change control, deviation and incidents. Knowledge and experience in equipment/facilities qualification