Site Quality Operations Leader

Importante entreprise Alger, Algérie
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  • Secteur d'activité Industries
  • Date d'expiration 30 Août
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Confirmé / Expérimenté
  • Niveau d'étude (diplome) Master 2, Ingéniorat, Bac + 5

Responsibilities:

  • The Site Quality Operations Leader is responsible for providing leadership in assuring that appropriate systems and processes are in place that meet or exceed the requirements of the company and the local regulatory authorities for the quality of the products manufactured on site or by approved contractors.This position has a dual reporting relationship, both to the Site Leader and to the Regional QO Leader Operations and will be a member of Algiers Site Leadership Team.
  • Key focus areas and responsibilities for this position include: Ensuring regulatory compliance;Overseeing all site quality operations functions and Site Quality Review Team (SQRT); Planning,implementing and achieving site quality operations objectives consistent with the site objectives and Global Quality Operations objectives; Providing leadership, development and direction to the QualityOperations team.
  • The Site Quality Operations Leader will lead, manage and develop a team with the responsibility of providing comprehensive support and guidance to all operations at the site in assuring Pfizer's Quality Standards are met. The incumbent must be capable of interacting with diverse stakeholders in different levels of the organization, from representatives of external site organizations such as Regulatory, LMS BU, OpEx and Regional Quality as well as all internal site customers.
  • This position will: 1) identify and resolve quality, process, and Good Manufacturing Practices (GMP) problems; 2) manage overall process in evaluating site compliance to PQSs and implement appropriate actions; 3) manage the overall assurance and disposition of products produced in site or by approved contractors; 4) Ensure robust notification to management process is in place; 5) approve quality operations and production quality assurance reports and investigations for deviations from approved manufacturing processes or specifications; 6) review key quality and regulatory documentation and implement appropriate actions, 7) lead and engage the site quality review team (SQRT) and AQRT process to ensure site regulatory compliance 8) coordinate development of area training plans in order to manage the training, qualifications and educational needs of the Quality Operations colleagues; 9) develop and maintain an organizational structure consistent with the area needs and goals, including the preparation and administration of annual performance assessments and discussions; 10) develop the annual financial operating plan for the quality department, such as direct expense and staffing budgets with continued assurance of cost improvements; 11) manage the financial performance of the quality department and support both department and site Cost Improvement Projects (CIPs) to ensure goals are achieved or exceeded; 12) provide strategic leadership to QO; 12) be a voice for change and continuous improvement. 

Qualifications:

  • Bachelor's degree in Chemistry, Microbiology, Pharmacy or Chemical Engineering.
  • Master's degree preferred. At least 10 years directly related experience in pharmaceutical manufacturing and quality operations, or equivalent combination of work experience. At least 5 years of  demonstrated success leading and developing professional colleagues and developing a staffing /  organizational structure in a manufacturing environment. It is desirable to have a demonstrated success

Site Quality Operations Leader

Importante entreprise Alger, Algérie
Postuler

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