Data Integrity and eCompliance

Germer International - Pharmaceutical Recruiting; Allentown (Lehigh County); On-site; USD 120,000 - 140,000; Full time

Job summary

A pharmaceutical recruiting firm is looking for a Manager of Recruiting & Project Management to oversee data integrity compliance and qualification strategies at their Allentown site. Candidates should have a Bachelor’s degree in Chemistry or life sciences and over five years of relevant experience in regulatory requirements within the pharmaceutical industry, along with strong communication skills and the ability to work in a dynamic environment.

Qualifications

• More than five years of relevant experience.
• Demonstrated ability to train employees on compliance.
• Knowledge of Good documentation practices.

Responsibilities

• Lead gap assessments and perform DI risk assessments.
• Define validation strategy and review CSV deliverables.
• Ensure compliance of documentation throughout software lifecycle.

Skills

Excellent written and oral communication

Ability to adapt to a dynamic work environment

Multi-tasking on ongoing projects

In-depth understanding of regulatory requirements

Knowledge of Pharma domain

Education

Bachelor’s degree in Chemistry or life sciences

Minor in computer sciences

Tools

Chromatography systems

SCADA

DCS

Job description

Base pay range

$120,000.00/yr - $140,000.00/yr

Additional compensation types

Annual Bonus

Job title

Manager of Recruiting & Project Management at Germer International

Data Integrity and eCompliance Specialist

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.

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.
• 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

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance, Science, and Information Technology

Industries

• Pharmaceutical Manufacturing