AGC Biologics is looking for GMP Business Analyst at our site near Copenhagen, Denmark

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 aza@agcbio.com.

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 aza@agcbio.com.

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 !

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

Apply for this Job

* Required

First Name *

Last Name *

Email *

Phone *

Location (City) *

Resume/CV *

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

Cover Letter *

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

When autocomplete results are available use up and down arrows to review

+ Add another education

LinkedIn Profile URL

Website

If you are being refereed to AGC Biologics by a current employee, please enter their name below. *

Are you willing to relocate? *

Current Mailing Address: *

GDPR Consent *

Privacy information for sending job applications

Pursuant to art. 13 of Regulation (EU) 2016/679 (hereafter "GDPR"), laying down provisions for the protection of persons and other subjects regarding the processing of personal data, we wish to inform you that the personal data you provide will be processed in compliance with the aforementioned legislation.

AGC Biologics Inc., together with its parent company, its subsidiaries and affiliates (collectively, “AGC Biologics Group”, “we”, “us” or “our”), recognize the importance of protecting your privacy. This Policy is designed to assist you in understanding how we collect, use, safeguard and disclose your personal information when using the “join our team” service. We also describe how you can contact us about our privacy practices.

Data Controller

You are informed that your data is collected by the specific AGC Biologics Group company and processed in accordance with the applicable laws.

Type of data processed

By sending your curriculum vitae (CV), you are communicating your personal identification data concerning your training and work experience. Pursuant to articles 9 and 10 of the GDPR, you could give us data qualifying as "particular categories of personal data" (ie those data revealing "racial or ethnic origin, political opinions, religious or philosophical convictions, or union membership, data relating to the health or sexual life or sexual orientation of the person”). With reference to the processing of these particular categories of data, we inform you that, if not necessary for the purpose of completing the selection activity, it is preferable to avoid the inclusion in the CV of such sensitive data.

Purpose and legal basis

The personal data you provide are necessary to evaluate your potential suitability for the purpose of a possible inclusion within our staff.

The processing of data reported in your CV is based on your express consent in the act of sending the CV itself, accepting this Policy. We remind you that you may revoke your consent here expressed at any time, by means of a written communication to the Data Controller or using the “join our team” service. This does not prejudice the lawfulness of the treatment based on the consent given before the revocation. We invite you to promptly communicate any changes in the data furnished. We may contact you by email requesting your consent to conserve your CV for an additional period of time, basing said communication on our legitimated interest of maintaining a contact with you.

Optional supply of personal data

The provision of personal data indicated as required is necessary. Therefore, any refusal to provide such data would make it impossible to manage the relationship with you and would then cause the impossibility of your possible inclusion in our staff.

Method of treatment

The processing of personal data will be based on principles of correctness, lawfulness and transparency, protecting your privacy and your rights and will take place using suitable tools to guarantee their security.

Categories of recipients to whom personal data might be disclosed or communicated, scope of dissemination of personal data

With respect to the activities and purposes stated above, personal data will be processed exclusively by employees and / or collaborators of the Data Controller, also through third parties appointed as Data Processors (e.gg. business consultants or external companies in charge of maintenance of the “join our team” service and related activities), in compliance with the provisions of the law also with regard to security measures to protect and safeguard the data provided.

The list of Data Processors can be requested to the Data Controller.

The Data Controller may communicate and disseminate personal data for the sole purpose of executing legal obligations.

Data retention

The data collected will be kept for the time strictly necessary for their treatment and in any case no later than one year/six months, unless you authorize us to extend such period, following our written request.

International data transfer

Your personal data may be transferred to, and processed in, countries other than the country in which you are resident. These countries may have data protection laws that are different to the laws of your country (and, in some cases, may not be as protective).

Specifically, our servers are or will be located in the European Economic Area or EEA or any other country that is compliant with the principles of the GDPR, and third party service providers and partners operate around the world. This means that when we collect your personal data we may process it in any of these countries.

However, we have taken appropriate safeguards to require that your Personal Data will remain protected in accordance with this Policy. These include implementing an intra-group data transfer agreement based on the European Commission's Standard Contractual Clauses (the "Intra-Group Data Transfer Umbrella Agreement") for transfers of Personal Data between our group companies, which require all group companies to protect Personal Data they process from the EEA in accordance with the GDPR.

We have implemented similar appropriate safeguards with our third party service providers and partners and further details can be provided upon request.

Rights of the interested parties

Within the limits of the GDPR, you have the right to ask us, at any time, to access your personal data, to rectify or cancel them or to oppose their treatment, the limitation of processing and to obtain a structured format, in common use and readable by automatic device data concerning you.

Requests should be sent to the Data Controller using the address indicated in the position description.

In accordance with applicable law, you have, in any case, the right to lodge a complaint with the competent supervisory authority (Personal Data Protection Authority) if you consider that the processing of your personal data is contrary to the law in force.

More information on treatment

Defense in court

Your personal data can be used for the defense by us in court or in the stages of its establishment, in case of abuse in the use of our services.

You declare to be aware that we may be required to disclose the data at the request of the public authorities.

Additional information

You may request more information in relation to the processing of your personal data at any time using the contact information.

Changes to this privacy policy

We reserve the right to make changes to this privacy policy at any time by giving publicity to users.

Current Position *

Current Company

What are you current salary level? *