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La Multinationale Bayer recrute 3 Profils






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




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





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).