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

Requirements
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

Bachelor’s degree (B Pharm) with 4 6 years’ related work experience, or Post Graduate Degree/ Post Graduate Diploma with 2 4 years’ 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