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Chemical Manufacturing Control Documentation Creator

Detalles de la oferta

This job is with Bayer UK & Ireland, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Please do not contact the recruiter directly.
[[title]]             YOUR TASKS & RESPONSABILITIES   Authoring of CMCD (Module 3 and QoS) documents (TRDs) for Bayer's Consumer Health new and existing product pipeline in both New Product Development (NPD) and Post Approval Change (LCM) Under the guidance of senior team members, assist in the authoring of TRDs for NPDs.
Under the guidance of senior team members, author TRDs for renewals and annual reports for existing products (LCM).
Documentation admin in Veeva Vault and equivalent, for all TRDs for LCMs.
Support category continuous improvement initiatives.
Support relevant functional processes.
WHO YOU ARE   Bachelor's degree in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent, ideally with +1 years of prior hands-on experience in a technical role within the pharmaceutical, food or related industry (Analytical Development, Formulation Development, Manufacturing).
Experience within Medicinal Regulatory-CMC is highly advantageous.
Master's degree or higher, in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent.
Basic understanding of relevant product development processes.
Knowledge/understanding of ICH.
Knowledge of other quality systems guidelines is a plus.
Knowledge/understanding of USP, Ph.Eur.
and other relevant Pharmacopoeias.
Understanding of cGMP, principles of Quality Assurance and equivalent.
Analytical and problem-solving abilities, with ability to prioritize.
Communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
Good English communication skills, both written and verbal.
Other languages are a plus.
Detail-oriented with the ability to maintain accurate documentation and records.
Ability to work independently and as part of a team in a fast-paced global environment.
YOUR APPLICATION       This is your opportunity to tackle the world's biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change.
You have a voice, ideas and perspectives and we want to hear them.
Because our success begins with you.
Be part of something big.
Be Bayer.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
We are committed to treating all applicants fairly and avoiding discrimination.
Location: [[mfield3]]     Division: [[filter1]]    Reference Code: [[id]]  #LI-DNI


Fuente: Talent_Dynamic-Ppc

Requisitos

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