Analyst, Pharmaceutical Development

Hikma Pharmaceuticals; Sintra; On-site; EUR 32,000 - 42,000; Full time

Benefits offered by this job

Life insurance

Health Insurance

Job summary

Hikma Pharmaceuticals Portugal seeks an Analyst, Pharmaceutical Development (m/f) to join the on-site Pharmaceutical Development team. You will stay up to date with regulatory and quality standards, perform method validation and stability studies, and support CoAs and documentation.

The role requires a bachelor’s degree in chemical engineering or chemistry, lab experience, and knowledge of cGMP and SOPs. Hikma offers a direct contract, competitive salary, life/health insurance, and growth

Qualifications

• Bachelor’s degree in chemical engineering, chemistry or similar.
• Knowledge of regulatory and quality standards (GXP) and ability to follow SOPs.
• Experience in analytical lab environments and ability to operate lab equipment and software.

Responsibilities

• Stay updated with regulatory and quality standards (GXP) globally.
• Perform method validation, verification, transfer and stability samples and generate reports/CoAs.
• Manage process validation batches and stability samples for filings; support document management and audits.
• Act as primary contact for sites to support product introductions.

Skills

Analytical skills

Teamwork

Problem solving

cGMP knowledge

Education

Bachelor’s degree in chemical engineering or chemistry

Tools

Analytical instruments

Laboratory software

Job description

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 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