Technical Writer, Production

Sintra, Lisboa
Permanente
Horário completo

Há 7 dias

Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people who are competent. 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, Production (m/f) to integrate Production - Hikma I - Line 5 Department, on-site work.Main Responsibilities:

Stays updated with internal quality standards, evolutions in GxP/GMP compliance and best practices.
Performs/evaluates/writes root-cause investigation and impact analysis for production reports (critical, major, minor, and environmental monitoring deviations) according to current standards and procedures.
Working together with Operators/Production Lines Supervisors/Manager defines robust CAPAs based on root cause analyses and trending of reoccurring Production Investigation Reports.
Writes Production reports (MEMO's, Protocols, Reports, Media Fill Reports, ASSR, etc).
Acts as a SME for Production reports and gives training to individuals (i.e Quality Circles, re-trainings) as well as classrooms (annual cGMP training program).
Performs montly presentations with relevant Quality data findings that are observed during investigation reports issuance.
If necessary, can support overall documentation revision / update (SOP's, executed MBR, MBR, etc).

Profile:

Degree in Technicial / Science, Engineering or medical fields
Proactive
Organized
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)
Computer Skills (Word, Excel, PowerPoint)
Fluency in English, wirtten & spoken

We offer:

Direct contract with Hikma
Salary appropriate to the functions performed
Life insurance
Health insurance
Annual Performance Bonus
High career prospects

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

Hikma Pharmaceuticals

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