Project Manager

The Remas Company; La Verne (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading firm in Pharma and Biotech is looking for a Project Manager to manage GxP compliance and validation for SAP S/4 HANA. The ideal candidate should have over 8 years of experience in Computer System Validation and at least 3 years managing large global SAP validation projects. Candidates should possess excellent communication skills and a thorough knowledge of GxP regulations and 21 CFR Part 11. This role requires the ability to lead teams and adapt in a dynamic environment.

Qualifications

• 8+ years in Computer System Validation in Life Science domain.
• Minimum 3+ years of experience in managing large global SAP validation projects.
• Excellent knowledge of GxP regulations and FDA guidelines.

Responsibilities

• Lead and perform validation activities for SAP S/4 HANA.
• Manage and maintain validation for the SAP system.
• Perform GxP assessments and develop validation plans.

Skills

Excellent communication (oral and written)

Attention to detail

8+ years in Computer System Validation

3+ years in managing large global SAP validation projects

Self-motivation

Adaptability

Positive attitude

Knowledge of GxP regulations

Knowledge of 21 CFR Part 11

Knowledge of GAMP-5 standards

Job description

Should know GxP, Validation and possibly MES

GxP Documentation is must

Seeking a Project Manager with experience inPharma/ Biotech/ Life Sciences/ Medical Device/ Healthcare or Manufacturing a must (Okay with either industry)

Responsibility:

• This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, and GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11.
• Leads the effort to manage, and/or maintains validation of SAP S/4 HANA system.
• Perform GxP and 21 CFR part 11 assessments and develop validation plan.
• Develop functional risk strategy and perform functional risk assessment.
• Review user business process documents and user requirements specification.
• Review functional, technical and configuration design documents.
• Prepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols.
• Review the test scripts for the requirements and test scenario coverage.
• Lead overall protocol executions, log and track defects.
• Review the executed test reports for the proper documentation of test results and evidence.
• Review the defects for proper documentation per the checklist.
• Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested.
• Prepare and approve qualification summary report.
• Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.
• Maintain overall project and issue tracker and report routinely.
• Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release.
• Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials.
• Maintain day to day activities status tracker and report routinely.
• Lead the team of validation engineers located in different time zones.

Skills:

• Excellent communication (oral and written) and attention to detail.
• 8+ years in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projects.
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
• Excellent knowledge of GxP regulations, FDA and EMEA (European Medicines Evaluation Agency ) guidelines including 21 CFR Part 11.
• Excellent knowledge of computer system validation and GAMP -5 standards.