Quality Assurance Manager

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  • Nom de l'entrprise Abdi Ibrahim Remede Pharma
  • Secteur d'activité Industries
  • Lieu de travail Alger, Algérie
  • Date d'expiration 17 Septembre
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Confirmé / Expérimenté
  • Niveau d'étude (diplome) Master 1, Licence Bac + 4

Abdi Ibrahim Remede Pharma, recherche pour ses besoins:

Quality Assurance Manager (H/F)

 

RESPONSIBILITIES:  

  • The Quality Assurance Manager provides functional, technical or process leadership.
  • Aims to ensure that the product or service an organization provides is fit for purpose, is consistent and meets both external and internal requirements. 
  • This includes legal compliance and customer expectations.
  • Coordinates the activities required to meet quality.
  • Designs and implements programs, policies, procedures and follows practices to ensure that all functions in the company are in compliance with International and Local regulatory requirements.

Key Responsibilities :

  • Oversees work processes used throughout the organization to assure that they conform to established standards.
  • Manages changes in systems or procedures when necessary to improve quality or maintain compliance.
  • Researches quality or compliance issues and recommends changes for improvements. Disseminates information on compliance requirements and initiatives.
  • Responds to requests from regulatory agencies. Leads in the creation of reports and documentation needed for regulatory bodies.
  • Sets standards for quality as well as health and safety
  • Defines quality procedures in conjunction with operating staff
  • Monitors and advises on the performance of the company’s quality system, produces data and reports on performance, measuring against set standards.
  • Liaises with other managers and staff throughout the organization to ensure that the quality system is functioning properly.
  •  Where appropriate, advises on changes and their implementation and provides training, tools and techniques to enable others to achieve quality.
  • Devises and establishes company's quality procedures, standards and specifications
  • Reviews product specifications and ensures that they are met
  • Works with procurement staff to establish quality requirements from external suppliers
  • Makes sure that manufacturing or production processes in house and at external manufacturing facilities meet international and national GMP standards
  • Sets up and maintaining controls and documentation procedures
  • Monitors performance by gathering relevant data and produces statistical and Key Performance Indicators reports
  • Oversees internal audits, vendor audits and vendor qualification, corrective and preventive action system, non-conforming materials, Material Review Board, calibration program, and document control. 
  • Oversees product quality reviews, management reviews and preparation of quality reports. 
  • Ensures that all projects and validations are in compliance with requirements. 
  • Ensures dependable and timely results from quality control, including process control and support for process changes in compliance with requirements. 
  • Participates in regulatory inspections and customer audits. 
  • Participates in evaluation of new product opportunities.  
  • Identifies and implements opportunities for continuous improvement. 
  • Interacts and coordinate activities with other departments, external vendors and customers. 
  • Evaluates the performance of the Quality Department employees with the intent of increasing their competency. 
  • Collaborates with other departments (e.g., Risk Management, Internal Audit etc.) to direct compliance issues to appropriate existing channels for investigation and resolution.
  • Responds to alleged violations of rules, regulations, policies, procedures, and initiates investigative procedures.
  • Ensures that compliance issues/observations/concerns within the organization are being appropriately evaluated, investigated and resolved.
  • Ensures proper reporting of violations or potential violations of GMP or regulatory standards to corporate Quality Assurance as appropriate and/or required.
  • Works with the Human Resources Department and others as appropriate to develop an effective compliance training program, including appropriate introductory training for new employees as well as ongoing training for all employees and managers.

EDUCATION:     

  • Bachelor’s Degree in Chemistry, Pharmacy or related University degree 
  • English as a second language is a must.
  • Familiarity with management systems, including the ISO 9000, total quality management (TQM), continuous improvement process, as well as quality assurance procedures and regulations is a must.


EXPERIENCE:    

  • Prior Service -- 5-7 years of relevant experience in quality assurance and regulatory practices.
  • Production and Processing -- Knowledge of raw materials, finished dosage forms production processes, quality control.
  • Personnel and Human Resources -- Knowledge of principles and procedures for personnel selection, rewarding, training and talent management.
  •  Computers and Electronics -- Knowledge of computer hardware and software, including applications
  • Coaching and Developing Others -- Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.
  •  Developing Objectives and Strategies -- Establishing long-range objectives and specifying the strategies and actions to achieve them.
  • Communicating with Persons Outside Organization -- Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
  • Resolving Conflicts and Negotiating with Others -- Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
  • Complex Problem Solving -- Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
  • Project Management -- Experience with project management lifecycle, processes, and tools.

CHARACTERISTICS:  

  • Ability to effectively work in large, cross-functional project teams with subject matter experts of quality, manufacturing operations, supply chain management, process engineering, product development, commercial, legal, finance.
  • Solid analytical and creative problem solving skills  as well as strong leadership skills and capable to effectively communicate at all levels
  • Excellent organizational and work management skills
  • Effective interpersonal and communication and presentation skills
  • Ability to exercise good judgment, independent decision making and complex problem solving skills
  • Dynamic, self-motivated, pro-active approach to taking on challenging assignments.
  • Creativity and judgment 
  • Ability to work with critical timelines and resilience under pressure. 
  • High level of personal integrity.

 

Vous ne pouvez pas postuler à une offre expirée
  • Nom de l'entrprise Abdi Ibrahim Remede Pharma
  • Secteur d'activité Industries
  • Lieu de travail Alger, Algérie
  • Date d'expiration 17 Septembre
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Confirmé / Expérimenté
  • Niveau d'étude (diplome) Master 1, Licence Bac + 4
  • Adresse : 02 route de douira, baba hassen Alger 16000
  • Industries
  • De 100 à 250 personnes employés