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Quality Assurance Manager - Glob...

Global Napi Pharmaceutic...
6th of October, Giza

Quality Assurance Manager - Global Pharmaceutical Industries

6th of October, GizaPosted 23 days ago
72Applicants for1 open position
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Job Details

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Job Description

1- Compliance:

  • Ensures that all manufacturing process is in compliance with Good Manufacturing Practices (GMP), established internal procedures ( S.O.P.) and as specified by appropriate international GMP standards (e.g. WHO, EU, FDA).
  • Secures the compliance with the quality requirements according to national & international standard ( ISO 9001).

2 - SOP Management:

  • Issues and reviews The Standard Operating Policies (SOP) related to The Technical Directorate (Production, Quality Departments, Warehouse & Engineering)
  • Ensures that all Company's Standard Operating Policies (SOP) is complying with the standard agreed format. 
  • Participates in project-based activities (e.g., continuous improvement to associated processes and related SOP's) in support of departmental goals.

3- Technical Activities:

  •  Authorizes the final product release.
  • Initiates the product recall & follow up its implementation provided that this action has   been approved by the Quality Director.
  • Serves as a departmental technical resource related to the QC testing activities in terms of Pharmacopoeia Requirements.
  •  Solves technical problems related to product quality.
  • Assists in resolving issues encountered in the assay documentation, Out of Specification     Reports (O.O.S.) and Investigation reports.
  • Assesses the appropriateness of Corrective Actions Preventive Actions (CAPA) items proposed in assay documentation. 
  •  Works cross-functionally to resolve issues & discrepancies and to develop any preventive actions to secure the products from any incidents that may cause product turning back, recall or even client's complaints.
  • Works closely with the manufacturing management to improve procedures related to quality.
  •    Sets procedures that ensure the correct handling of materials & documents.
  •  Issues & reviews the Calibration Program.  
  •  Issues & reviews the Validation Program.(Process, equipment, cleaning & system validation)
  •  Issues & reviews the system for Deviation and Change Control Management.
  •   Issues & reviews Annual Product Review.
  •  Secures the calibration of all reading devices, as well as the calibration & validation of all equipment's by inspecting them on a routine basis. 
  •  Performs self-audits on a regular basis.
  •  Performs external-audits on suppliers on a regular basis.
  •  Represents the Company in all Toll-Manufacturing Audits & is responsible to deal with the resulted  NCR's and to take the corrective actions.

4- Complaints:

  •  Receives and records the complaint.
  •  Carries out the necessary investigation and route cause identification.
  •   Assigns the Corrective & Preventive Actions and ensures that the complaint file is safely closed.

5- Training Activities:

  • Carries out Periodical Training on GMP requirements for all Managers, Staff  level & Workers throughout the various departments of the Company as per requirements of various regulatory agencies including documentation, system compliance, stability, analysis, in-process quality assurance, validations, etc.
  • Assures that the concerned employees are trained on GPI Quality Management (Q.M.) policies and procedures, and ISO 9001 requirements.

6- Departmental Activities:

  •  Manages & supervises departmental employees, assigns work and special projects, monitors workload and productivity, evaluates performance and promotes staff training.
  •  Identifies the required technical training for departmental employees and cooperates closely with HR Manager on issues of training, development, vacation schedules and makes proposal for hiring, firing, promotions, bonus and salary increases.
  •  Determines and identifies the risk and emergency situations in the department.
  •  Identifies records and updates the various aspects within the department and their impact on the cGMP

Job Requirements

Qualifications :

Pharmacist , not less than 20++ years experience , at least 5 years in a similar position as QA manager in reputable companies.

Proven experience in managing sterile production environments, and ensuring compliance with regulatory guidelines

Proficiency in managing quality systems as CAPA , Deviation  management , CCR, CCS , and computer system validations

Experience in quality risk management , and mitigation strategies for sterile operations

Comprehensive knowledge of regulatory requirements , including EMA, WHO, FDA ….etc

Strong leadership , team management, and cross functional collaboration skills

Ability to handle trouble shoot, and resolve issues related to sterile manufacturing processes

Excellent experience in conducting internal /external audits

Excellent experience in handling CAPAs raised from different regulatory bodies or authorities

Excellent skills in providing training on sterile management practices

V. good knowledge for using EPR system , and excellent computer skills

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