Quality Assurance and Validation Officer at Estrada International Staffing Solutions

Job objectives:

Our client, a prominent player in the pharmaceutical sector, is seeking a dedicated and experienced Quality Analysis Validation Officer to join their team. 

As a crucial member of the quality assurance team, you will be responsible for ensuring that the quality of products consistently meets cGMP, local, and international standards. This includes validating processes, systems, utilities, equipment, and methods to ensure compliance.

Principal Duties / Responsibilities 

Management of Site Validation and Calibration Activities:

• Oversee validation activities for HVAC, Equipment Qualification, Cleaning Validation, Manufacturing Process Validation, Utilities, etc.
• Coordinate the qualifications, validations, and calibration programs for factory equipment, analytical equipment, processes, and products.

Support for Technology Transfer:

• Ensure the validation of the manufacturing process during Technology Transfer activities.

Execution of Validation Activities:

• Maintain systems in a validated state through proper execution of validation activities from planning to execution.
• Lead and execute the Commissioning and Qualification (C&Q) of validation projects.

Protocol Management:

• Ensure all validation or qualification activities follow defined protocols.
• Manage deviations, changes, and ensure appropriate follow-up for closure with defined CAPA or implementation actions.

Documentation and Reporting:

• Timely approval and execution of Validation Master Plans (VMP) and new validation/qualification needs.
• Interface with process owners and other departments to ensure systems align with the Validation Life Cycle Approach.
• Provide assistance to external auditors in compliance reviews.

Quality Assurance and Operational Objectives:

• Ensure quality assurance operational objectives are met by contributing information and analysis to strategic plans.
• Complete action plans, identify and resolve problems, complete audits, and determine system improvements.

Risk Management:

• Implement Quality Risk Management (QRM) across all validation and qualification activities.

Commissioning and Decommissioning:

• Properly commission and decommission equipment as required.

Job Requirements

To be successful in the role, the candidates should meet the following requirements:

Educational Qualification:

• B.Sc./HND in Sciences and related disciplines. Computer literacy is an added advantage.

Technical Skills:

• Effective communication, interpersonal, and team player skills.
• Analytical, problem-solving, and RCA skills.
• Sound knowledge of cGMP, Validation, and Qualification.
• Good understanding of local regulatory policies and requirements.
• Attention to detail.

Required Experience:

• Minimum of 5 years of practical experience in pharmaceuticals/food and beverages with knowledge of cGMP, Equipment Qualification, and Process Validation.