Officer, Documentation - Planning & Support Office

Hikma Pharmaceuticals; Sintra; Presencial; EUR 35 000 - 50 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Life insurance

Health insurance

Annual performance bonus

High career prospects

Resumo da oferta

Hikma Pharmaceuticals is seeking an Officer for its Documentation team in the Planning & Support Office in Sintra, Portugal. The successful candidate will maintain internal quality standards and manage documentation for manufacturing processes.

This role requires a Bachelor's degree in a related field and 3–5 years of experience in pharmaceutical operations or quality departments. Candidates must be proactive and fluent in English. Benefits include health insurance and performance bonuses.

Qualificações

• 3–5 years in Pharmaceutical Operations and/or Quality Department is preferable.
• Knowledge of pharmaceuticals manufacturing processes.
• Proficient in quality systems management.

Responsabilidades

• Stay updated with internal quality standards and GMP compliance.
• Generate/revise master batch records and bill of materials.
• Perform/evaluate root-cause investigations and impact analysis.
• Work with operations supervisors to propose/define CAPAs.
• Issue a monthly report on activities performed and KPI status.

Conhecimentos

Fluency in English, written & spoken

Proactive and organized

Ability to work independently and in a team

Computer skills (Word, Excel, PowerPoint)

Familiar with root cause analysis techniques

Formação académica

Bachelor’s degree or equivalent in technical/science, engineering, or medical fields

Ferramentas

GMP’s

Pharma quality standards

GXP quality assurance

Descrição da oferta de emprego

Officer, Documentation - Planning & Support Office

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 900 employees and 3 factories for the production of injectable medicines.

Hikma intends to recruit an Officer, Documentation (m/f) to integrate the Planning & Support Office Department, on‑site work, reporting to the Manager, Planning & Support Office – Cláudia Costa.

Main Responsibilities

• Stays updated with internal quality standards, GMP compliance and best practices.
• Generates/Revises master batch records and bill of materials for inspection, labelling and packaging activities for commercial products, new launches and submissions, in agreement with the relevant change controls.
• Generates/revises procedures (APAIs, VPAIs, Wis) in agreement with the relevant reports, risk assessments and memos related to manufacturing activities.
• Performs/evaluates root‑cause investigations and impact analysis for manufacturing operations in Hikma 3 building and writes them in agreement with current standards and procedures.
• Works together with operations supervisors/ managers to propose/define CAPAs based on root cause analysis and trending of recurring investigations.
• Issues memos for manufacturing operations in Hikma 3 Building.
• Gives support to planning activities when needed.
• Issues a monthly report to record the activities performed and KPI status, and an analysis regarding the investigations for manufacturing operations in Hikma 3 building and implemented CAPAs.

Profile

• Bachelor’s degree or equivalent in technical/science, engineering, or medical fields.
• 3–5 years in Pharmaceutical Operations and/or Quality Department (preferable).
• Proactive and organized.
• Ability to work in a highly structured environment and work independently and as part of a team.
• Fluency in English, written & spoken.
• Computer skills (Word, Excel, Power Point).
• Pharmaceuticals manufacturing process (GMP’s).
• Pharma quality standards & systems management.
• GXP quality assurance.
• Familiar with root cause analysis techniques and product impact tools (e.g. FMEA).

Benefits We Offer

• Direct contract with Hikma.
• Salary appropriate to the functions performed.
• Life insurance.
• Health insurance.
• Annual performance bonus.
• High career prospects.