Manufacturing eSystems Specialist
Alvotech · Reykjavik
Job description
About the role
This role manages electronic execution systems in manufacturing, working closely with Subject Matter Experts from each manufacturing function and with Quality Assurance. It covers electronic batch records, e-logbooks and documentation, and involves training staff, adapting to new systems and improving them.
Key responsibilities
- Manage electronic execution systems, including Master Control Electronic Batch Records for USP, DSP and Dispensing, SAP for manufacturing, and e-logbooks in manufacturing.
- Oversee the creation, upkeep and review of electronic batch records, and if required SAP master recipes, process orders, reservations and consumption processes.
- Review Veeva documentation required for eBR and eSystems (CC, CAPA, DEV).
- Provide training to employees on the use of eSystems where required.
- Adapt to the administration of new eSystems as they are introduced into manufacturing.
- Initiate and implement improvements to the systems in use.
- Act as Subject Matter Expert for validation and qualification documentation and collaborate with IT to test and implement solutions that improve efficiency and meet quality standards.
- Deliver assigned projects independently and on time, and contribute to team objectives through collaboration and knowledge sharing.
Required profile
- BSc or Diploma in a technical discipline such as pharmacy, biotechnology, biochemistry, engineering or a related field.
- 3-5 years of experience in the pharmaceutical industry or a related industry preferred.
- Team player with strong organisational skills.
- Excellent written and verbal communication skills and excellent command of English.
Required skills
- Proficiency with a PC and common Microsoft packages such as Word, Visio and Excel.
- Familiarity with electronic batch record systems and e-logbooks.
What we offer
- A global, fast-growing company with an international, inclusive work culture.
- Support for personal growth and internal career development.
- Social events and milestone celebrations.
- In-house canteen and coffee house, exercise and wellbeing support, and an on-site shower facility.
- Transportation grant and internet at home for full-time employees.
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Published 11 klukkutímar síðan
Expires 1 mánuður síðan
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Alvotech
Reykjavik
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