Analyst, Pharmaceutical Development

Hikma Pharmaceuticals; Sintra; Presencial; EUR 32 000 - 46 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Direct contract with Hikma

Competitive salary aligned with the Ro

Life insurance

Health Insurance extended to student/0

Resumo da oferta

Hikma Pharmaceuticals is seeking an Analyst, Pharmaceutical Development (m/f) to join the Pharmaceutical Development team on-site in Portugal. The role involves staying current with regulatory and quality standards, performing analytical method validation and transfers, and supporting documentation and audits.

You will collaborate across teams to ensure compliant development and filing for new products. The ideal candidate has a degree in chemical engineering or chemistry, strong analytical lab

Qualificações

• Bachelor’s degree in chemical engineering, chemistry or similar.
• Demonstrated knowledge of working in an analytical lab environment, of the cGMPs, and ability to follow SOPs and policies.
• Demonstrated ability to operate and troubleshoot analytical techniques and equipment/software.
• Capability of working with others and as part of a team; good problem-solving skills.

Responsabilidades

• Stays updated with regulatory and quality standards, GXP compliance and best practices worldwide.
• Performs method validation, verification, transfer and stability analysis and generates reports and CoAs.
• Manages process validation batches and stability samples for filings across geographies and presentations.
• Supports management of critical documents and CAPA; preparation of quality management and audit reviews.
• Acts as primary contact for sites to support the introduction of assigned products.

Conhecimentos

Analytical lab experience

cGMPs knowledge

SOP adherence

Teamwork

Formação académica

Bachelor’s degree in chemical engineering or chemistry

Ferramentas

Laboratory equipment operation

Descrição da oferta de emprego

Analyst, Pharmaceutical Development

Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people in need. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.

At the end of the 1980s, we extended ours beyond the Middle East and acquired land in Portugal for the construction of a sterile factory for injectable pharmaceutical products. This was an important turning point for the company, and our first step into a new region. Today, in Portugal, we have more than 1000 employees and 3 factories for the production of injectable medicines.

Hikma intends to recruit an Analyst, Pharmaceutical Development (m/f) to integrate the Pharmaceutical Development, working on-site.

Main Responsibilities:

• Stays updated with regulatory and quality standards, evolutions in GXP compliance and best practices where needed everywhere in the world
• Performs required Method validation, verification, transfer and stability samples analytical work and fills out relevant documentation, including generating reports and filling CoAs.
• Performs request, label and management of assigned products process validation batches and stability samples for the new geographical and presentations filings.
• Supports the management of critical documents and CAPA in addition to the preparation of quality management and audit reviews
• Acts as primary contact for the related sites to support the introduction of assigned products for the identified purpose
• Ability to remain update in all analytical techniques required.

Profile:

• Bachelor’s degree in chemical engineering, chemistry or similar;
• Demonstrated knowledge of working in an analytical lab environment, of the cGMPs, and should have the ability to follow SOPs and policies;
• Demonstrated ability and skill to perform required analytical techniques and to operate and troubleshoot the associated equipment and software;
• Capability of working with others and as part of a team is essential; Good problem-solving techniques is needed to make necessary adjustments and to prioritize tasks.

We offer:

• Direct contract with Hikma
• Competitive salary aligned with the role
• Life insurance
• Health Insurance extended to student children (up to age 24)
• Annual Performance Bonus
• Real Growth Opportunities

If you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every day.