QS Compliance Specialist

Aspen Pharma Group; Gqeberha; On-site; ZAR 450 000 - 600 000; Full time

Job summary

A leading pharmaceutical company in Gqeberha is seeking a Quality Assurance Specialist to coordinate quality activities and ensure compliance with regulatory standards. Responsibilities include preparing for audits, improving quality processes, and maintaining documentation. The ideal candidate holds a Bachelor's Degree in Pharmacy or a related field, has 4-6 years of experience, and possesses strong knowledge of pharmaceutical standards. This role offers an opportunity to contribute to the continuous improvement of quality compliance.

Qualifications

• 4-6 years of related work experience in quality assurance.
• Experience in pharmaceutical manufacturing.
• Knowledge of QMS is advantageous.

Responsibilities

• Coordinate quality activities and implement quality procedures.
• Prepare for regulatory audits and compile documentation.
• Participate in site audits and compile audit responses.
• Assist with documentation for external customers.
• Review policies and procedures to meet compliance.

Skills

Pharmaceutical standards and compliance requirements

People skills

Report writing skills

Knowledge of regulatory guidelines

Education

Bachelor’s Degree (BPharm) or relevant scientific qualification

Job description

Coordinate quality activities, including:

• Interpret and implement quality procedures, standards and specifications
• Preparation of regulatory audits
• Action all audit related activities and responses
• Pro actively initiate continuous improvement activities to improve quality compliance under the guidance of the QS Management

Audit Readiness and Performance

• Participate in site walkabouts and prepare department owners for upcoming audits
• Compile documentation required for external audits
• Review compliance status of the facility and highlight risks to the quality team
• Prepare teams and documentation prior to presentation to the auditors
• Co ordinate activities and documentation requests during site audits

Audit CAPA Management

• Liaise with department owners to compile audit responses to external audit observations, according to the required standard
• Maintain status updates of the audit CAPA actions for both internal and external audits
• Timeously prepare external audit responses for submission

Operational Support

Track continuous improvement actions identified and ensure effective implementation thereof

Assist with preparation and review of documentation requested by external customer and regulatory bodies

Take part in project risk assessments for introduction of new products/facility changes

Policy, procedure and document management

• Provide input into policies and procedures with regards to latest authority expectations
• Draft and maintain SOPs relevant to the functions performed by the department
• Review site procedures for compliance to regulations and Group Operations Quality Compliance

Review and reporting

• Compile audit CAPA update reports for submission to external and internal stakeholders
• Update the Quality CES audit matrix with the latest status of observations

Background/experience

• Minimum of Bachelor’s Degree (BPharm) or relevant scientific qualification
• Knowledge of regulatory guidelines
• Minimum 4-6 years’ related work experience
• Pharmaceutical manufacturing experience
• QMS experience is advantageous
• Regulatory audit experience is advantageous

Specific Job Skills

• Strong working knowledge of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• People skills and working well with others
• Report writing skills

Competencies

• Offering Insights
• Taking Action
• Information gathering
• Interrogating information