QA Pharmacist - East London, South Africa - Aspen Pharma Group

Aspen Pharma Group

Verified Company

East London, South Africa

1 week ago

Posted by:

Thabo Mthembu

beBee Recruiter

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

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