La Multinationale Bayer recrute 3 Profils:
-Technical Project Manager.
-Technicien Physico-Chimie.
-Regulatory Affairs Manager.
Bayer est une entreprise internationale dont l’histoire a commencé il y a plus de 150 ans. L’entreprise siège à Leverkusen, en Allemagne.
En 2018, Bayer comptait près de 117 000 salariés et a réalisé un chiffre d’affaires de 39,6 milliards d’euros. Ses investissements se sont élevés à 2,6 milliards d’euros et le Groupe a consacré 5,2 milliards d’euros à la recherche et au développement.
Le groupe Bayer est engagé en matière de responsabilité sociétale et soutient les principes de développement durable dans toutes ses activités. Ceci aboutit à la mission à l’essence même de notre mission: Science for a Better Life, la science pour une vie meilleure.
Nos activités couvrent des secteurs aussi variés que les spécialités pharmaceutiques, les médicaments délivrés sans ordonnance, compléments alimentaires et produits d’automédication, la santé animale et la protection des cultures. Elles impliquent à la fois les médecins, les pharmaciens et les vétérinaires, les agriculteurs et les consommateurs.
Les secteurs concernés par nos activités sont très spécifiques et en même temps, ils ont beaucoup de points communs. Dans le domaine de la recherche et du développement (R&D), nous travaillons sur les processus biochimiques au niveau cellulaire de tous les êtres vivants, processus qui sont étonnamment similaires. L’innovation reste le fondement de notre stratégie et de notre culture.
Chez Bayer, l’innovation ne se limite pas à la R&D: elle s’applique à tous les échelons de l’entreprise. Nos salariés sont en permanence à la recherche de nouvelles voies d’amélioration de la qualité de nos produits et de nos services.
La Multinationale Bayer recrute 3 Profils
Technical Project Manager
Major tasks and responsibilities:
-Collaborate with engineers, architects etc. to determine the specifications of the project
-Negotiate contracts in collaboration with Procurement with external vendors to reach profitable agreements
-Ensures full compliance for projects in accordance with Bayer Regulations
-Obtain permits and licenses from appropriate authorities
-Determine needed resources (manpower, equipment and materials) from start to finish with attention to budgetary limitations
-Plan all construction operations and schedule intermediate phases to ensure deadlines will be met
-Acquire equipment and material and monitor stocks to timely handle inadequacies
-Hire contractors and other staff and allocate responsibilities
-Supervise the work of laborers, mechanics etc. and give them guidance when needed
-Evaluate progress and prepare detailed reports
-Ensure adherence to all health and safety standards and report issues
Work relations Internal:
-Site Manager / BU head
-Site Mgmt. Team – as member
-Production / Quality
-Human Resources -Engineering / Technology / Maintenance
-QHSE, Supply Chain Management and Procurement
-Controlling
External:
-Service providers/contractors
-Suppliers
-Customers
-Authorities / Auditors
Qualifications (Education, skills, experiences)
-Proven experience as construction project manager
-In-depth understanding of construction procedures and material and project management principles
-Experience in Pharmaceutical Industries Projects and GMP.
-Familiarity with quality and health and safety standards
-Good knowledge of MS Office
-Familiarity with construction/ project management software
-Outstanding communication and negotiation skills
-Excellent organizational and time-management skills
-A team player with leadership abilities
-Diploma in Engineering, building science or relevant field
-PMP or equivalent certification will be an advantage
-Language Skills: Arabic, French and English is a must for this position
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Technicien Physico-Chimie
Major Tasks and responsabilities:
-Parfaite maîtrise des équipements d’analyse HPLC, CPG ; ICP, Spectrophotométrie ….
-Maîtrise du logiciel EMPOWER
-Participe à la mise à jour des instructions au laboratoire.
-Parfaite maîtrise des techniques des validations (validation de nettoyage ; validation analytique ; validation de process …)
-Expérience en Data Intégrité
-maîtrise et connaissance des conditions de mise en stabilité des produits finis selon ICH
-Gestion des déchets chimique au laboratoire
-Gestion des réactifs et des consommables du laboratoire
-Expérience en microbiologie sera un atout important
-Parfaite connaissance des exigences des BPF et BPL
-maîtrise de SAP (Bay4S)
Who you are:
-Technicien de laboratoire Physico /chimique dans une Industrie Pharmaceutique
-Expérience plus de 5 ans dans un poste similaire.
-Technicien de laboratoire de formation chimique ; licence ou master.
-Parfaite maîtrise de Français et Anglais
-Esprit d’équipe et bonne communication
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Regulatory Affairs Manager
Purpose:
Assesses and proposes regulatory strategies, defines data requirements and submission strategies for existing marketing authorisations and new marketing authorisation applications for medicinal products in Algeria & Tunisia. Provides regulatory support, recommends strategy and define data requirements for other legal categories (cosmetics, medical devices and food supplements) in Algeria & Tunisia. Responsible for the maintenance of existing marketing authorisations and product information a compliant manner according to local requirements. Advises internal partners on regulatory issues and risks associated with regulatory/submission strategy, presenting available options and making recommendations. Scope (global, regional or local): Local: Algeria and Tunisia
Key Tasks:
-Member of the North African cluster CH Regulatory team. Participation in relevant meetings supporting and providing regulatory input, strategy & contributions
-Supports the implementation of regulatory strategy, tailored to the special needs of the country o by developing and implementing appropriate registration strategies, ensuring lifecycle product management process, from timely and high-quality dossier submission, getting approvals, ensure follow up until MA termination/withdrawal, and update regulatory systems o Interaction with the relevant Health Authorities by conducting negotiations and providing product consultation on RA matters as well as providing input following relevant RA assessments.
-Ensures compliance by o adherence to industry-specific codes of practice or conduct, advertising codes, regulatory directives and guidelines, as applicable to the role, and to the Program for Legal Compliance and Corporate Responsibility at Bayer.
-Implementing global processes according to RA relevant Quality System Document and contribution to local gap analysis, conducting archiving with adherence to local and global SOPs & to local regulatory guidelines.
-Actively support the local organization with product-related issue and risk management activities. o Monitors the requirements of the Algerian & Tunisian Health
-Authorities regarding legislative changes by maintaining a legislation tracker
-Ensures compliance with SOPs and relevant local legislation in order to safeguard products’ compliance for respective area of responsibility.
-Represents effectively Bayer to local Health Authorities, by providing necessary information and cultivating excellent relationships in a compliant way.
-Contributes to company’s license to operate
-Contributes to the implementation of portfolio activities by assuring life cycle management of products and compliance
Key Working Relation:
Internal:
-Regional & Global Regulatory Affairs
-Local business organization (local Marketing, Medical department, Drug Safety & Quality, Product Supply)
External:
-Health Authorities of Algeria & Tunisia
-3rd party providers
Qualification & Competencies:
-Life sciences University degree; MSc will be considered as an asset
-At least 3 years’ experience in Regulatory affairs in the area of OTC, as well as preferably medical devices, cosmetics and food supplements.
-Good knowledge of national regulatory requirements and experience in managing national registration procedures.
-Ability to communicate effectively and assertively with sound negotiation skills.
-Commercial awareness, good project management skills, ability to adapt to changing priorities.
-Cross functional working ability
-Adequate digital/IT skills (as an end user) – Ability to quickly adopt new technologies.
-Fluency in English and French (both written and verbal).
