- Developing and implementing IT compliance policies and procedures
- Conducting regular audits and assessments to ensure compliance.
- Coordinating with IT staff and business units to ensure compliance with GMPs and other regulatory requirements.
- Identifying areas of non-compliance and developing corrective action plans.
- Keeping up-to-date with changes in GMPs and other regulatory requirements
- Providing guidance and training to IT staff and business units on IT compliance requirements
- 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.
- Develops, manages, implements improvement projects and provide administration of certain GMP applications.
- 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
Qualifications:
- Bachelor's degree in Computer Science, Information Systems, or related field
- Minimum of 6 years of experience in IT compliance, preferably in a GMP environment
- Strong knowledge of GMPs and other regulatory requirements, including 21 CFR Part 11, Annex 11, and EU GMPs
- 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.
- Proven expertise in project management – planning/organization/execution of IT systems lifecycle management.
- Experience with IT auditing and risk assessment methodologies
- Excellent communication and interpersonal skills
- Strong analytical and problem-solving skills
- Ability to work independently and as part of a team.
- Ability / experience in managing cross functional IT projects
- 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.
