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).
About offre emploi maroc
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