• Pharmaceutical Industry
  • Alt Penedès, Spain
  • Contract
    • Indefinite
    • Full-time
    • Fixed gross salary not specified
  • 29 registered
Offer description
Etalentum selects for a company dedicated to the production and marketing of food products, an adjunct Technical Director, who following the guidelines of the Technical Director, must perform the following functions:

? Take care that each batch of pharmaceutical specialties has been manufactured, controlled and conserved according to the law.
? Be permanently and continuously available to the holder of the manufacturing authorization.
? Endorse with your signature all technical-health documents.
? Approve and take responsibility for all the technical documentation related to the registration of medicines and the authorization of the laboratory.
? Ensure proper compliance with the specifications authorized for each medicine for which the laboratory is authorized to manufacture.
? Guarantee the application of the Rules of Correct Manufacturing.
? Approve the manufacturing and control procedures, as well as the required documentation.
? Authorize the release to the market of each batch of pharmaceutical specialties.
? Assist the authorities in the exercise of their inspection functions.
? Order the withdrawals of lots from the market when necessary and communicate this resolution to the authorities involved.

The Deputy Technical Director will also act as the pharmacovigilance manager of the laboratory:
? Create and maintain a system to collect, process and evaluate information on suspected adverse reactions reported to company staff and medical sales representatives, in order to make it accessible in at least one place in the EU
? Prepare and submit periodic safety reports to the AEM.
? Ensure that a prompt and complete response to any request for additional information from the AEM necessary to evaluate the benefits and risks of the medicine, including information regarding the volume of sales or prescriptions of the medicine in question, is given.
? Provide the AEM with any other information of interest for the evaluation of the benefits and risks associated with a medicine, including information on post-authorization safety studies.

The Deputy Technical Director will also act as head of the Quality Control department:
? Review the documentation, to approve or reject raw materials, packaging materials and intermediate products, in bulk and finished, always according to the Rules of Proper Manufacturing.
? Supervise the sampling processes as indicated by the corresponding procedures and always respecting the GMP.
? Participate in the validation and revalidation processes that the Quality Assurance unit considers necessary.
? Supervise and approve the processes of product analysis and control.
? Review and accept returns.

Offers:
- Become part of a consolidated company in the sector.
- Immediate incorporation.
- Indefinite contract.
Minimum studies
- Bachelor of pharmacy or other higher qualification equally qualified in accordance with current regulations.
Minimum experience
- Minimum experience of 2 years.
Minimum languages
- Catalan.
- Spanish.
- English.