Norwich Pharmaceuticals Inc
Sr. Manager Computer System Validation
Norwich Pharmaceuticals Inc, Norwich, New York, United States,
SUMMARY OF POSITION
The CSV Sr. Manager is responsible for planning, writing, implementing, and reviewing computer system validation protocols of GxP computerized systems. Evaluate, propose and implement technology solutions that improve digitization, compliance and productivity. Serve as the CSV subject matter expert and provide guidance on and interpretation of GxP guidance and regulations of computerized systems, electronic records/signatures, and data integrity requirements. Collaborate with peers across Alvogen on procedures relating to quality, data integrity and Computer system validation.
ORGANIZATION STRUCTURE
The CSV Sr. Manager reports to the VP of IT. There will be no direct reports.
RESPONSIBILITIES
Primary responsibilities of this role include the following:
CSV:
Drafting validation plans, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ) and final validation reports.
Review and approve other CSV related deliverables such as User Requirements (URS), Functional Specifications (FS) and Design Specifications (DS).
Leading the resolution of any data integrity or critical quality issues related to IT Quality Management.
Involved in the continuous improvement of Alvogen’s IT quality management system and computer systems validation.
Manage (where applicable) outside vendors in the effort to complete validation required activities.
Support project teams in the review and QA approval of system validation in accordance with FDA guidelines.
Contribute expertise and provide guidance on 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participate in assessment.
Leadership:
Establish necessary policies and procedures regarding SAP management. Periodically review policies and procedures for compliance and supply necessary information for SOX/IT audits.
Lead the SAP Security Administrator in establishing procedures for security management.
Site SAP lead for large NPI projects that involve production, plant maintenance, and quality management.
Establish working relationships and leadership to contractors and consultants for large system rollouts.
Lead for QUMAS SAP documentation structures and use.
SAP Maintenance & GxP:
Generate system documentation for configuration or development associated with GxP processes.
Review SAP Audit trails.
Contributes to Global Validation team for system validation documentation including validation plans, protocols, reports and risks assessments.
Maintain continuity on validation documentation for original implementations and new sites rolling on.
QUALIFICATIONS
At least 8 years experience with validation of computerized systems, specific expertise in ERP and Laboratory systems highly preferred.
Minimum 6 years experience in working with quality systems and GMP environment of pharmaceutical manufacturing.
Attention to detail, thoroughness, and willingness to learn are desired attributes.
Good communication skills.
Manufacturing industry experience with a good understanding of business processes and information flow throughout the business.
Strong Knowledge of ERP fundamentals.
Ability to assist users in solving systems problems.
Ability to read and interpret technical manuals used in the implementation of a new organization unit.
Ability to maintain records, write reports and create presentations.
Excellent organizational skills.
Self starter and a team player.
Minimum travel.
GMP DECISION-MAKING AUTHORITY
Approves GMP documentation related to computerized systems or computerized system components.
This role will offer a base salary that is commensurate with experience and demonstrated skills in the $145,000 - $155,000 range.
An Equal Opportunity Employer, including disability/vets.
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The CSV Sr. Manager is responsible for planning, writing, implementing, and reviewing computer system validation protocols of GxP computerized systems. Evaluate, propose and implement technology solutions that improve digitization, compliance and productivity. Serve as the CSV subject matter expert and provide guidance on and interpretation of GxP guidance and regulations of computerized systems, electronic records/signatures, and data integrity requirements. Collaborate with peers across Alvogen on procedures relating to quality, data integrity and Computer system validation.
ORGANIZATION STRUCTURE
The CSV Sr. Manager reports to the VP of IT. There will be no direct reports.
RESPONSIBILITIES
Primary responsibilities of this role include the following:
CSV:
Drafting validation plans, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ) and final validation reports.
Review and approve other CSV related deliverables such as User Requirements (URS), Functional Specifications (FS) and Design Specifications (DS).
Leading the resolution of any data integrity or critical quality issues related to IT Quality Management.
Involved in the continuous improvement of Alvogen’s IT quality management system and computer systems validation.
Manage (where applicable) outside vendors in the effort to complete validation required activities.
Support project teams in the review and QA approval of system validation in accordance with FDA guidelines.
Contribute expertise and provide guidance on 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participate in assessment.
Leadership:
Establish necessary policies and procedures regarding SAP management. Periodically review policies and procedures for compliance and supply necessary information for SOX/IT audits.
Lead the SAP Security Administrator in establishing procedures for security management.
Site SAP lead for large NPI projects that involve production, plant maintenance, and quality management.
Establish working relationships and leadership to contractors and consultants for large system rollouts.
Lead for QUMAS SAP documentation structures and use.
SAP Maintenance & GxP:
Generate system documentation for configuration or development associated with GxP processes.
Review SAP Audit trails.
Contributes to Global Validation team for system validation documentation including validation plans, protocols, reports and risks assessments.
Maintain continuity on validation documentation for original implementations and new sites rolling on.
QUALIFICATIONS
At least 8 years experience with validation of computerized systems, specific expertise in ERP and Laboratory systems highly preferred.
Minimum 6 years experience in working with quality systems and GMP environment of pharmaceutical manufacturing.
Attention to detail, thoroughness, and willingness to learn are desired attributes.
Good communication skills.
Manufacturing industry experience with a good understanding of business processes and information flow throughout the business.
Strong Knowledge of ERP fundamentals.
Ability to assist users in solving systems problems.
Ability to read and interpret technical manuals used in the implementation of a new organization unit.
Ability to maintain records, write reports and create presentations.
Excellent organizational skills.
Self starter and a team player.
Minimum travel.
GMP DECISION-MAKING AUTHORITY
Approves GMP documentation related to computerized systems or computerized system components.
This role will offer a base salary that is commensurate with experience and demonstrated skills in the $145,000 - $155,000 range.
An Equal Opportunity Employer, including disability/vets.
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