*Sr. GMP Business Analyst
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The GMP Business Analyst’s role is to work closely with the business to plan, design, develop, implement and launch efficient supply chain, financial, manufacturing and operations systems. This includes gathering
Sr. GMP Business Analyst
AGC Biologics is looking for Sr. GMP Business Analyst at our site near Copenhagen, Denmark.
GMP Business Analyst Job Duties:
- Quality is the responsibility of each employee at AGC. Each employee is expected to perform his/her tasks diligently and in compliance with requirements in AGC’s Quality System
- Possesses the primary responsibility to elicit, analyze, validate, specify, verify, and manage the needs of the business stakeholders and end users, and serve as the conduit for requirements around GMP systems.
- Provides strategic direction for GMP IT operations (e.g. supply chain, quality and manufacturing)
- Defines GMP IT standards for services, systems, hardware, and security
- Develops, manages, implements improvement projects and provide administration of GMP applications and certain instruments
- Develops and maintains standards for procedures for GMP applications
- GMP systems support: Implementation, validation protocol creation and execution, maintenance, documentation, administration, problem resolution & RCA
- Operations support: GMP processes, GMP documentation (SOPs, CRs, CAPAs, etc.) and operational support as required
- Lead IT Audits
- Partner with Team members from multiple geographies
- Other duties as assigned
Skills and experience:
- 6+ years experience as a key participant in the design, development, implementation, support, and/or administration of GMP software and hardware solutions, or systems
- Proven expertise in project management – planning/organization/execution of IT systems lifecycle management – from RFP to retirement
- Performs varying complex duties with little/no direct supervision. Can work on long-term issues & projects where little/no instructions or guidelines exist. Able to multi-task on several projects while maintaining daily activities
- Ability to manage projects and achieve desired results within specified deadlines, and revising the work plan for complex problems being resolved by cross functional teams
- Working knowledge and practical experience of computer and application integration / validation (preferably using GAMP methodology), cGMPs, and 21 CFR Part 11 in an FDA regulated environment
- Knowledge of Software testing (FAT / SAT) and commissioning procedures
- Ability / experience in managing cross functional IT projects
- Ability to work hours necessary to support production and /or maintenance activities across multiple sites
- Excellent written and verbal English skills
- Experience in Biotech industry a plus
To be taken into consideration for the role, you must possess a valid Danish working permit.
Interested?
Send your application as soon as possible. We are reviewing and processing applications as we receive them and we urge you to submit your papers as sooner rather than later.
If you need further information about the position, please feel free to contact Head of CPH IT Apostolis Zafeiris at [email protected].
Want to keep posted about our growth and to learn more about our company?
We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !
AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.
and analyzing data in support of business cases, proposed projects, systems requirements, and administration. This individual will apply proven communication, analytical, and problem-solving skills to help maximize the benefit of IT system investments in AGC’s GMP application ecosystem to ensure that we meet all customer, business and regulatory requirements through the following activities:
- People & Team focus
- GMP focus
- Operational reliability & efficiency focus
GMP Business Analyst Job Duties
- Quality is the responsibility of each employee at AGC. Each employee is expected to perform his/her tasks diligently and in compliance with requirements in AGC’s Quality System
- Possesses the primary responsibility to elicit, analyze, validate, specify, verify, and manage the needs of the business stakeholders and end users, and serve as the conduit for requirements around GMP systems.
- Provides strategic direction for GMP IT operations (e.g. supply chain, quality and manufacturing).
- Defines GMP IT standards for services, systems, hardware, and security.
- Develop, manage, implement improvement projects and provide administration of GMP applications and certain instruments.
- Develop and maintain standards for procedures for GMP applications.
- GMP systems support: Implementation, validation protocol creation and execution, maintenance, documentation, administration, problem resolution & RCA
- Operation support: GMP processes, GMP documentation (SOPs, CRs, CAPAs, etc.) and operational support as required.
- Promoting a safe work environment.
- Partner with Team members from multiple geographies.
- Other duties as assigned.
Skills and Experience
- 3-5 years experience as a key participant in the design, development, implementation, support, and/or administration of GMP software and hardware solutions, or systems
- Proven expertise in project management – planning/organization/execution of IT systems lifecycle management – from RFP to retirement.
- Performs varying complex duties with little/no direct supervision. Can work on long-term issues & projects where little/no instructions or guidelines exist. Able to multi-task on several projects while maintaining daily activities.
- Ability to manage projects and achieve desired results within specified deadlines, and revising the work plan for complex problems being resolved by cross functional teams.
- Working knowledge and practical experience of computer and application integration / validation (preferably using GAMP methodology), cGMPs, and 21 CFR Part 11 in an FDA regulated environment.
- Knowledge of Software testing (FAT / SAT) and commissioning procedures
- Experience creating ad-hoc and routine reports using SQL Server Management Studio and Report Builder
- Ability / experience in managing cross functional IT projects
- Ability to work hours necessary to support production and /or maintenance activities across multiple sites
- Excellent written and verbal English skills
- Experience in Biotech industry is a plus
To be taken into consideration for the role, you must possess a valid Danish working permit.
Interested?
Send your application as soon as possible, we are reviewing and processing applications as we receive them and we urge you to submit your papers. If you need further information about the position, please feel free to contact Head of CPH IT Apostolis Zafeiris at [email protected].
Want to keep posted about our growth and to learn more about our company?
We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !
AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.
Information og data
Denne ledige stilling har jobtypen "Revisor", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 13.12.2022, men kan have været deaktiveret og genaktiveret igen.
- Revisor
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