Job Description

• 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)
• Related administrative tasks

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 analyzed; 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 analyze 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 standardized 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