Quality Assurance Pharmacist

Viatris; Kempton Park; On-site; ZAR 450,000 - 650,000; Full time

Job summary

VIATRIS™ is seeking a QA professional in Kempton Park to support quality management in a pharmaceutical manufacturing environment. The role focuses on timely product release, QA documentation, and regulatory compliance to SA GMP standards.

You will review investigations, support Change Controls, and maintain QA databases while training colleagues and assisting the Sales Team as needed. Minimum 2 years’ experience and a BPharm (Registered) are required.

Qualifications

• QA experience in a pharmaceutical manufacturing environment.
• Good inter-personal skills to liaise with other departments, customers, TP contractors and Global.
• Sound knowledge of SA cGMP requirements and best practices.
• Understand the requirements of the relevant Acts and regulations governing the pharmaceutical industry.
• Decisiveness, superior attention to detail and timely actions with respect to the Supply Chain.

Responsibilities

• Assist and maintain aspects of the Quality Management System, adhering to SA GMP requirements.
• Provide support to the business by timeous review of products for release.
• Assist with Quality Complaints investigations.
• Review and approve Non-conformance Reports, Change Controls and complete Master Batch Documentation Review.
• Ensure QA Database is accurately maintained.
• Train colleagues and provide timeous QA support to the Sales Team.

Skills

QA experience

Interpersonal skills

SA cGMP knowledge

Regulatory understanding

Trackwise

Education

BPharm (Registered)

Tools

Trackwise

Job description

VIATRIS™, is a new kind of healthcare Company, committed to providing access to medicines, advancing sustainable operations developing innovative solutions, and leveraging our collective expertise to improve patient outcomes. Formed in 2020, through the combination of Mylan and Up-John-Pfizer, Viatris bring together best in class scientific, Manufacturing and distribution expertise with proven regulatory, Medical and commercial capabilities to deliver quality medicines to patients when and where they need it.

Fast Facts

• Headquartered in the US with global centers in Pittsburgh (USA), Hyderabad (India) and Shanghai (China)
• Our global workforce of ~45000, includes expertise across scientific, manufacturing, regulatory and Commercial Operations
• Have ~ 50 Manufacturing Facilities across Oral Solid Doses, Injectables, Complex dosage forms and APIs
• Total 1400+ Molecules, have portfolio that treats nine out of ten WHO causes of death. Our 200+ medicines are on WHO essential medicines List
• We have commercial reach to 165+ Countries and territories

Job Function

• To assist and maintain aspects of the Quality Management System, adhering to SA GMP requirements and those of the Office of Global Quality.
• To provide support to the business by timeous review of products for release.
• To assist with Quality Complaints Investigations.
• To review and authorize Non-conformance Reports, Change Controls and complete Master Batch Documentation Review.
• To ensure that the QA Database is accurately maintained.

Primary Responsibilities

• Product Release and Supply– To ensure timeous QA release of stock from warehouse; to assess laboratory requirements for new product analysis; to assist in reviewing the monthly Schedule of Open Orders to set-up laboratories in advance of delivery of product; to compile the Monthly Metrics report on all Quality processes
• Third Party Manufacturers/Packers/FPRC – To assist with the review BMR/BPR/Stability & Validation Protocols & Reports and QC documentation to ensure accuracy and compliance with the registered dossier and to ensure accurate manufacture of Mylan products.
• To review and approve Third Party Change Controls and obtain all documentation required to compile an amendment to submit to SAHPRA; to prepare documentation required for Shelf-Life extension variations.
• Site Transfer Process – To assist the Team Leader for all Technical & Analytical method site transfers
• Perform actions required by the Quality Management System to include:
• Drawing up SOP’s
• Retention sample control
• Approved Batch documentation
• Annual Product Review
• Deviation/ Non-conformance Reports Control
• Change Controls
• SA GMP training
• Quality Complaints – to log and assist in required actions according to SOP and to train on and use Trackwise Quality Complaints system.
• To compile tables of comparison between existing and future sources of API and FDP.
• To prepare documentation required for Batch Specific Requests for SAHPRA submission
• To process Narcotics Import and Export Licenses and to assist with the quarterly reports to SAHPRA as well as the SAHPRA annual reconciliation.
• Applicant History – to assist with the review of Viatris Applicant files for compliance.
• To provide timeous support to the Sales Team
• Manage allocated projects as and when required
• Training – to provide training to colleagues.
• Performance Management – to complete monthly reports and bi-annual reviews with Quality Manager.
• Any other duties assigned by Senior Management

Key Knowledge/Skills Required

• Quality Assurance experience in a Pharmaceutical Manufacturing environment.
• Good inter-personal skills to liaise with other departments, customers, TP contractors and Global
• Sound knowledge of SA cGMP requirements and best practices
• Understand the requirements of the relevant Acts and regulations governing the pharmaceutical industry
• Decisiveness, superior attention to detail and commitment to timeous actions with respect to the Supply Chain

Education

• BPharm (Registered)

Experience

Minimum of 2 years’ experience in a manufacturing and/or quality environment within pharmacy