PRODUCT DEVELOPMENT PHARMACIST – Portfolio Pharmaceutical Botswana (Pty) Limited

 

Portfolio Pharmaceutical Botswana (Pty) Limited a pharmaceutical manufacturing company, is looking to hire a Product Development Pharmacist.

Duties and responsibilities include the following:

The Product Development Pharmacist will be responsible for pharmaceutical product development and associated activities by developing robust products and processes that are scalable, stable and bioequivalent to the Reference Product.

In addition to being responsible for complying with regulatory, company and local legislature.

• Performs trials for new products or products under redevelopment inside or outside the plant according to the predetermined procedures
• Prepare samples for stability, export & bio-equivalence studies.
• Documents and reports all trials observations and results according to the predetermined procedures
• Performs pilot trials and validation batches as directed
• Provides support to the Marketing function on the review and approvals of promotional materials
• Completes equipment qualification checks and prepares SOPs for working with the equipment
• Provides production input and ensures proper closure of Out of Specification (OOS) and deviations investigations plus correction action and preventative action (CAPAs)
• Complies with the applicable Good Manufacturing Practices (GMP) standards and procedures
• Supports training and education programs to ensure understanding and compliance of key processes
• Submits applications for product registration and variation as and when required
• Requests and reviews technical development data from contact givers considering requirements by regulatory authorities.
• Minimizes the company’s ‘risk’ and ensures continuity of product supply by pro-actively managing compliance issues in accordance with corporate, regulatory and legal standards
• Takes responsibility for the document management and data storage according to local laws and company policy and procedures
• Prepares monthly management reports on the activities and success of the product development, in addition to operational reports and regulatory reports

Key Requirements Skills, and Core Competencies:

• Pharmaceutical degree or similar (pharmaceutical sciences, chemistry)
• Must be qualified in accordance with Botswana Pharmacist Council and DRU
• Minimum of 5 years’ experience in the pharmaceutical industry
• Must be conversant with current BOMRA, WHO and industry practices and trends
• Sound understanding of the Good Manufacturing Practice
• Wide knowledge of products and processes used in the manufacture of licensed medicines
• Must be able to review, identify, collect and organize data for analysis and decision-making purposes
• Ability to prepare written communication, presentations & visual materials
• Excellent communication skills (both verbally and written)
• Strong sense of collaboration and team leadership to promote and achieve company objectives
• Must be able to generate new ideas and go beyond the status quo