Regulatory Affairs and QA Specialist

  • Nom de l'entrprise Importante Entreprise
  • Secteur d'activité Services
  • Lieu de travail Alger, Algérie
  • Date d'expiration 30 Décembre
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Confirmé / Expérimenté
  • Niveau d'étude (diplome) Licence (LMD), Bac + 3
Importante Entreprise

  • Importante Entreprise
  • Zeralda, Alger, Algérie
Voir toutes les offres de l'entreprise

Multinational company which opened in March 2010 a Scientific Office in Algeria with the aim to expand its own business in the Country, to this aim and to support the increase of local productions-linked activities, the companyis seeking aJunior Regulatory and QA specialist to take over the new position as soon as possible.

 

Job purpose

  • Supporting the Responsible Pharmacist in the registration and maintenance of the company portfolio products in the Country and taking over of the quality-related responsibilities relevant to the local production activities.

 

Job description:

The Junior Regulatory and QA specialist is responsible for providing support to the Responsible Pharmacist in the submission, progress and follow-up of regulatory dossiers and documentation for new products, re-registrations, line extensions and renewals in Algeria. The above will apply to pharma products and potentially also to Consumer Health products such as food supplements, medical devices, cosmetics. The Junior Regulatory and QA specialist is also responsible for ensuring all the tasks relevant to local production evaluation and performance are carried out in line with the defined timelines and standards, this will include but will not be limited to site due diligence and audit; in performing this duty  he/she will work in cooperation with local suppliers/manufacturers and third commercial parties.

 

In order to reach the high targets of the existing organisation the Junior Regulatory and QA specialist:

  • prepares and revise the documentation for the pre-registration of company products portfolio and perform a pre-screening of the available data in order to verify the compliance of the dossier with local regulation,
  • support the Responsible Pharmacist concerning regulatory activities in order to meet agreed timelines for new product launches, line-extensions, re-registrations, renewals, licence variations and follow-up till these procedures are positively finalised,
  • ensures that the regulatory dossiers and documents are properly archived according to HQ standards and in compliance with local regulation,
  • prepares and revise the artworks in cooperation with Corporate editing both for regulatory purposes and for the incoming product launches,
  • perform due diligence to third party manufacturers with the aim to find potential partners able to manufacture locally the comapny products in full GMP compliance and in compliance with the company quality and safety standards,
  • organises and coordinates all the activities needed for the start-up of a new local production project, verifying to be in compliance with the agreement in place with subcontractors, and with the optimization of costs and timelines,
  • coordinates and follows the technology transfer activities in cooperation with Corporate QA in order any operation needed to switch imported products to local production or start new local productions is performed within the agreed timeline,
  • perform regular audit to the third party manufacturer

Knowledge experience/skills required:

In order to meet the high demands of the position, we are looking for a candidate with an outstanding profile.

The successful candidate will demonstrate:

  • years of relevant pharmaceutical experience with:
    • a minimum of 2years experience in Regulatory Affairs/Quality Assurance.

 

  • thorough working knowledge of local regulations and GMP guidelines.
  • wide spread experience with manufacturing activities such as technology transfers, technical verifications, GMP compliance, auditing of suppliers.
  • experience with regulatory procedures for the achievement and maintenance of product registrations, including lifecycle management and issue management with reference to both new and well established products.
  • excellent regulatory and technical knowledge in pharmaceuticals, biotechnology, medicinal, and nutritional products, including licensing and patenting.
  • excellent interpersonal skills, with the ability to work effectively across departments, functional and cultural areas.
  • excellent communication skills in English and french languages.
  • Degree in pharmacy or equivalent degree (life science)
  • Availability to travel

 

  • Nom de l'entrprise Importante Entreprise
  • Secteur d'activité Services
  • Lieu de travail Alger, Algérie
  • Date d'expiration 30 Décembre
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Confirmé / Expérimenté
  • Niveau d'étude (diplome) Licence (LMD), Bac + 3
Importante Entreprise

  • Importante Entreprise
  • Zeralda, Alger, Algérie
Voir toutes les offres de l'entreprise

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