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Validation Coordinator 47 views

Job Overview

  • Salary Offer Market Related
  • Experience Level Manager
  • Total Years Experience 0-5

Purpose:

A global pharmaceutical company focused on agile and sustainable growth and complex generics is seeking a Validation Coordinator who will be responsible for ensuring that qualification of utilities is carried out in accordance with OTC manufacturing procedures and policies, cGMP and relevant guidelines

 

Minimum Requirements:

  • Bachelor’s Degree in Mechanical/ Electrical Engineering / Biotechnology and Biochemistry
  • Experience in the pharmaceutical industry with at least 3 years in validation, qualification and utility support
  • Knowledge of HVAC, water for injection, purified water, compressed air and clean steam and nitrogen systems
  • Demonstrated ability to provide technical solutions for complex problems through qualification knowledge
  • Proficient in the use of structured problem-solving tools such as process mapping with regards to RCA, FMEA’s
  • In depth understanding of utilities and engineering
  • Excellent communication and interpersonal skills
  • Ability to work independently

Key Job Outputs:

General

  • Coordinate timely completion of utilities qualification in support of manufacturing activities and regulatory requirements
  • Write, review and execute qualification protocols and reports
  • Provide technical support to all departments in accordance with established service level agreements and company standards
  • Generate, execute and review completed qualification protocols and associated data for conformance to applicable acceptance criteria
  • Plan and execute utilities qualification plans to ensure that the manufacturing site is compliant to manufacture products
  • Compliance to regulatory and cGMP
  • Support compliance inspections and enquiries from regulatory agencies
  • Provide technical expertise during audits
  • Participate in internal audits as required
  • Achieve qualification excellence through robust and reliable processes to ensure compliance with manufacturing product quality systems and c0GMP regulatory requirements
  • Standardize validation approaches ensuring consistency of application in accordance with agreed timelines and schedules
  • Ensure that utilities qualification is performed as per approved schedule
  • Identify training requirements to support utilities qualification programme
  • Review and approve qualification protocols and assessments from a quality system documentation perspective
  • Generate validation documentation including deviations, risk assessments, traceability matrices and validation reports
  • Review and approve user specifications associated with utilities
  • Implement CAPAs on improvements and provide technical support in troubleshooting and maintenance
  • Review and approve specifications associated with utilities qualification
  • Maintain validation documentation system
  • Ensure compliance to all local site company policies, procedures and corporate policies
  • Compile and use SOPs based on current guidelines
  • Review and manage change control for utility qualification implications
  • Perform periodic reviews of site quality systems in order to maintain validation status
  • Keep abreast of latest regulatory and GMP requirements and implementation
  • Initiate and drive continuous improvement programs within operations

Core Competencies:

  • Analysing
  • Deciding and initiating action
  • Delivering results and meeting customer expectations
  • Planning and organising
  • Writing and reporting
  • Applying expertise and technology
  • Coping with pressure and setbacks
  • Achieving personal work goals and objectives
  • Adhering to principles and values
  • Relating and networking
  • Presenting and communicating information
  • Working with people

 

Salary:   Market related

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.

All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013

  • This job has expired!
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