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Pharmaceutical Development Laboratory Analyst
2 semanas atrás
Description:
- Founded in 1987 in Jordan, by Mr. Samih Darwazah, Hikma's purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve.
In 2000, we successfully passed FDA inspections for our manufacturing plants in Portugal. Our Injectables business also expanded into the lyophilized segment of the injectables market with the acquisition of a specialized manufacturing plant in Italy, and we moved into the oncology market with the acquisition of Ribose Pharm and Thymoorgan in Germany.
In 2005, the Group was listed on the London Stock Exchange, raising gross proceeds of US$124 million. A successful initial public offering enhanced our flexibility to grow the business both organically and through acquisitions. From 2005 onwards, we have expanded our presence in the MENA region and also made significant acquisitions in Europe and the United States to strengthen our Injectables business.
Currently, we are looking for a Pharmaceutical Development Laboratory Analyst (M/F) to be part of Hikma Portugal.
The work in PD department includes performing laboratory analysis of different techniques (including but not limited to HPLC and GC), testing multiple development samples at different stability time points, managing to find the best analytical method by understanding the principles and following literature plus experimental evaluation, performing method of analysis validation activities, plus testing using any other wet chemistry techniques. The analyst should also be responsible to review Laboratory Documentation and train new analysts.
**Job description/Main Responsibilities**:
- Design experiments on different method to find the best differentiating one
- Follow the documentation system and the capability to adhere to the cGLP and cGMP
- Perform method of analysis validation for different techniques, knowledge on HPLC and GC and familiarity with Empower Software is mandatory
- Help in setting up SOP’s for the different instruments and laboratory operations
- Monitor the stability program of the development samples and carry-on testing as per the provided protocol
- Coordinating and interacting with different departments in the facility to arrange and agree on the work plan
- Provide training to new or existing laboratory staff
- Prepare and review documentation (analytical validation methods protocols, reports and others) ensuring all procedures are followed
- Have Team Spirit and Collaboration as well as Critical Thinking appreciation.
- Technical understanding of GMP practices, analytical theory and techniques;
- Proactive attitude towards work and learning new techniques.
- Good time management skills.
- Good organizational skills.
- Fluency in English is a requirement (speaking and writing)
**Qualification/Experience**:
- MSc Degree in Chemistry; Chemical Engineering, or any other related fields
An experience (in R&D or other related departments) is considered valuable due to the nature of the work.
- If you think this is a good opportunity for your professional career, join us and contribute to better health, within reach, every day.
**What we offer**:
- Base salary
- Discretionary bonus
- Meal
- Fuel
- Life insurance
- Health insurance
- Location: Sintra, Sintra, PT