Job Description

Overview

Conduct in process compliance to quality procedures, standards and specifications for value stream operations. Review and approve quality related activities for value streams. Identify and provide solutions to systematic issues. Review Annual Performance Quality Review (APQR) and perform related administrative tasks.

Responsibilities

Planning and Process

• Provide technical and operational input during drafting of plans and procedures specific to unit.

Process Compliance

• Execute day to day QA activities for value streams
• Identify systematic technical and process issues by reviewing CAPA requests and trends
• Systematic investigation of the root causes of identified problems and risks for corrective action or prevention
• Develop CAPA plans and change incidents to address process compliance
• Implement operational changes to SOPs and processes, in compliance with control processes
• Ensure deviations (planned/ unplanned) and concessions are documented, reviewed, and analysed; and recommend validation activities to be performed
• Execute change control process by ensuring changes are documented, reviewed and approved

Annual Performance Quality Review

• Review APQRs to assess production risks and quality of in process control programs
• Review and analyse CAPA plans to assess impact on quality procedures and standards

Retention Sample Management

• Store and manage retention samples as per guidelines

In-Process Quality Management

• Review and approve outcome of in process internal inspections

Reporting

• Monitor the storage of documents on the soft and hard copy filing systems
• Maintain and update records and systems as required
• Provide information for reports on weekly/monthly basis, as required by superior
• Compile standardised reports and consolidate documents

Skills Required

Background/experience

• Bachelorxe2x80x99s degree (B Pharm) with 4 6 yearsxe2x80x99 related work experience, or Post Graduate Degree/ Post Graduate Diploma with 2 4 yearsxe2x80x99 related work experience
• Pharmaceutical manufacturing experience

Specific job skills

• Advanced understanding of the pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Information Gathering
• Interrogating Information
• Offering Insights
• Taking Action

Aspen Pharmacare