Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize…
Skills: Computer System Validation, GxP Regulations, 21 CFR Part 11, Data Integrity Risk Assessment, GAMP5
iMaker Group is renowned for its expertise in luxury villas, hospitality, and commercial developments. We are a dynamic consortium of companies offering comprehensive services in master planning, architecture, interior d…
Skills: 3D Architectural Animation, Video Editing, 3ds Max, Blender, Cinema 4D
Would you like to make a difference to the environment? Do you want to work for a global and ethical company? Join us and help us provide energy-efficient solutions that make a difference to the environment? We make what…
Skills: Order Management, Project Management, Order to Cash Cycle, SAP, International Trade Regulations
Who are we and what we stand for? Our purpose and mission are what guides us and represents our promise to all our stakeholders – customers, partners, employees, influencers, shareholders, and communities. Schneide…
Skills: SCADA system design, Substation automation, Communication network engineering, HMI visualization, Cybersecurity
Overview We Are PepsiCo PepsiCo is a leading name in North Africa’s food and beverage industry, where our products are enjoyed by consumers daily across the region. We offer a robust portfolio of beloved brands like PEPS…
Skills: Data Analysis, Data Visualization, Microsoft Excel, Power BI, Tableau
About SSE SSE is a leading engineering consulting firm specializing in high-rise buildings, complex structures, and landmark developments. We take pride in delivering excellence through innovation, precision, and commitm…
Company Description Veolia aims to be the benchmark company for ecological transformation. Our mission to “Resource the world” demonstrates the unwavering commitment of our 220,000 employees to creating a positive impact…
Overview We Are PepsiCo PepsiCo is a leading name in North Africa’s food and beverage industry, where our products are enjoyed by consumers daily across the region. We offer a robust portfolio of beloved brands like PEPS…
Skills: Strategic Planning, Project Management, Stakeholder Management, Regenerative Agriculture, Water Use Efficiency
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Full-time
bachelor degree
Posted 66d ago
~40 hrs/week
Responsibilities
The E-Compliance Section Head ensures all manufacturing equipment and site utilities comply with GxP and 21 CFR Part 11 regulations. The role focuses on implementing technical controls and risk assessments to prevent data manipulation across the site lifecycle.
Requirements
Requires a Bachelor's degree in pharmaceutical sciences and 7-10 years of CSV experience within a pharmaceutical manufacturing facility. Expertise in GAMP5, 21 CFR Part 11, and automation systems like PLC and SCADA is essential.
Full job description
Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.
The E-Compliance Section Head ensures that all manufacturing machines, equipment, laboratory instruments, and site utilities comply with GxP regulations and 21 CFR Part 11 requirements. This role focuses on preventing data manipulation by establishing rigorous technical controls across the entire site lifecycle.
Key Responsibilities
Technical Controls
User Access: Enforce unique user IDs and restrict administrative privileges to non-production personnel.
Audit Trails: Verify that automated audit trails capture the "who, what, when, and why" of all data modifications.
Data Backup: Implement and test automated, secure backup and archival processes to prevent data loss.
Security Levels: Map out and restrict system access based strictly on defined operational roles.
Qualification & CSV Risk Assessment for
Equipment Oversight: production machines and instrument.
Instrument Control: oversight analytical laboratory instruments compliance with QC compliance responsible from CSV point of view.
Utility compliance: Review computerized control systems for site utilities (e.g., Purified Water, HVAC, BMS, CA, etc.).
Risk Assessments: Execute Data Integrity Risk Assessments (DIRA) to identify vulnerabilities to data manipulation for all site GXP related systems &/ premises.
Alarm Review: Evaluate alarm configurations and audit trail records to identify unauthorized process overrides.
Compliance & Data Integrity
Data Anti-Manipulation: Design system configurations that eliminate the ability to delete or overwrite raw data.
Audit Defense: oversight the site's CSV and Part 11 compliance posture during regulatory agency inspections.
CAPA Management: Investigate computer system deviations and implement corrective actions for compliance gaps.
Qualifications & Experience
Automation: Deep understanding of PLCs, SCADA systems, Distributed Control Systems (DCS), and Historians.
Lab Systems: Technical knowledge of standalone software for laboratory instruments and chromatography systems.
Bachelor’s degree in pharmaceutical sciences with previous CSV experience is a must.
7-10 years of CSV experience specifically within a pharmaceutical manufacturing facility.
Comprehensive expertise in GAMP5, 21 CFR Part 11, EU Annex 11, and PIC/S guidelines.
Excellent communication in English language is a must.
This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!
Related keywords
CSVGxP21 CFR Part 11GAMP5EU Annex 11PIC/SPLCSCADADCSHistoriansData IntegrityDIRACAPAPharmaceuticalsQuality AssuranceAudit Trails
Acino is a Swiss pharmaceutical company headquartered in Zurich, with a clear focus on high-growth markets. We deliver quality pharmaceuticals to promote affordable healthcare and leverage our high-quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out-licensing.
For more information: www.acino.swiss
*** By engaging with Acino on LinkedIn (or any other Acino social media channel), you are agreeing to our Social Media Community Guidelines. If you do not agree to them, do not engage with Acino on social media. Please read our detailed community guidelines carefully here: https://acino.swiss/social-media-community-guidelines ***
How many Engineering jobs are open in New Cairo City, Egypt right now?
There are currently 128 open engineering positions in New Cairo City, Egypt listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in New Cairo City, Egypt?
Companies currently hiring include SYSTRA, PepsiCo, Schneider Electric, AESG, Ecolab, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in New Cairo City, Egypt?
Yes — 36 of the 128 open engineering positions offer remote or hybrid work (0 remote, 36 hybrid).
How do I apply for Engineering jobs in New Cairo City, Egypt?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.