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.
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
· 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.