Validation Coordinator 47 views

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