Oferta de trabalho

Technical Affairs Specialist – New Production Introduction (m/f)
Hikma Farmacêutica Portugal is recruiting a Technical Affairs Specialist – New Production Introduction for its Technical Affairs Department

Hikma, a pharmaceutical company that is a reference in its market, namely without a generic segment, is committed to meeting current health needs with high quality products, which are returned to everyone. Awaiting the recent growth, we are looking for a Technical Affairs Specialist – New Production Introduction (m/f)  for our Sintra facilities. Accepting our challenge, form an initial and continuous training program integrated in a dynamic and positive environment.

We value the sense of responsibility, a taste for challenges, proactivity, motivation and teamwork as well as autonomy, empathy and transparency. 

Main Responsibilities:

Technical lead and support to activities related to the manufacture of New Products (liquid and lyophilized sterile injectable products), which imply the following main tasks:

·         Issuance and revision of R&D, scientific and technical documentation

.         Work with R&D  teams on the technical/scientific discussions related to the critical process parameters for the manufacture of new products.

.         Preparation of Process Validation Protocols, Process Validation Reports and Master Batch Records for new products (R&D and Tech. Transfer)

·         Monitoring of the manufacturing of the Submission/Process Validation batches

·         Technical support to Regulatory Affairs team in the filing of new products in EU, MENA and US markets & response to Deficiency letters (DL’s)

·         Technical and scientific support to routine production and any related investigations.

·         Act as a point-of-contact on ongoing projects

·         Working knowledge of the international guidelines and regulatory requirements applicable to the pharmaceutical field, including FDA, EMA and ICH. 

.        Update, revision and creation of Standard Operating Procedures (SOP’s)

.       Problem solving of quality events (for new products) such as deviations, OOS results and establishment of the correspondent CAPAs -preparation of deviation/investigation reports.

.       Work in a Quality Risk Management basis for the Technology Transfer and manufacture of new products

 

Experience and Competencies:

·         Master’s Degree in Pharmaceutical Sciences

·         Experience with Windows operating system

·         Understanding/knowledge of Laboratory & Pharmaceutical Industry practices

·         English Intermedium/Advanced Level

·         Project management skills, problem solving & decision maker

·         Initiative & Drive for Results

 

We offer:

·         Direct employment contract with the company

·         Salary package adequate 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, accessible to everyone, every day.

Localização:    
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No caso de alguma dificuldade técnica contacte a Equipa de Suporte via e-mail porHRSupport@hikma.com.