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Job Title:  Quality Assurance Specialist

Organisation: Abacus Parenteral Drugs Limited (APDL)

Duty Station:  Mukono, Uganda

Reports to: Quality Assurance Manager

About Organisation:

Abacus Parenteral Drugs Limited (APDL) is a state of the art manufacturing facility that seamlessly integrates hi-tech engineering services into the building design. From the exterior view, the 36-acre APDL campus exudes careful planning, the interiors of the facility reveal thoughtful and spot on detailing. The facility is designed with materials and finishes that allow ample natural light thus conserving energy and still maintain high cleanliness standards and minimize maintenance. The entire facility is designed to meet the CGMP requirements.

Key Duties and Responsibilities:

Quality Management

• Development and maintenance of the organization’s Quality Management Systems in accordance with current applicable regulatory requirements and Internal Quality policy.
• To periodically review and update organizations standard policies and procedures in alignment with current regulations governing the pharmaceutical industry.
• Periodic review of all quality functions and procedures for appropriateness and validity.
• Periodic review and continuous improvement of existing SOPs, specifications and work systems with respect to current guidelines.
• Develop quality systems, procedures and amendments and monitor implementation and effectiveness of the same.
• Monitoring of compliance with the requirements of current Good Manufacturing Practices and internal procedures.
• To approve or reject starting materials, packaging materials, intermediate, bulk and fished products IN THE ABSENCE OF THE QA manager.
• Provide quality guidance and participation in conducting Risk management activities, including, Risk identification, Risk analysis, FMEA, Risk mitigation and communication.
• Participate in investigation of recalled/returned products/complaints.
• To conduct the self-inspection and/or quality that regularly appraises the effectiveness and applicability of the quality assurance system.
• Conduct training with respect to GMP, GLP, Safety, hygiene, application and principles of Quality Assurance.
• Participate in vendor audit in order to qualify new suppliers and re-qualify existing suppliers.

Customer Service

• To provide the customers with adequate confidence that those goods, when received and used, will conform to their specifications/requirements and fully meet the customer’s and regulatory compliance requirements.

Records Management

• Retention and destruction of records

Operational Controls

• To plan and execute QA activities within the budgeted resources effectively and efficiently

Qualifications, Skills and Experience:

• Bachelors of Pharmacy
• Registered with Pharmaceutical Society of Uganda
• A relevant Postgraduate qualification is an added advantage.
• Five years of progressive experience, preferably in a busy pharmaceutical/healthcare industry.

Training Requirements:

• Basic safety training
• Basic GMP training
• Leadership training

Competencies:

Required Skills:

• Report Writing Skills
• Influencing Skills
• Budget management skills
• Analytical Skills
• Presentation skills
• Good communication & interpersonal Skills
• Computer Skills (PPt, Excel and MS Word)
• Negotiation skills
• Strategic thinking
• Conflict Management
• Able to learn and adapt to change.
• Innovative / creative skills.
• intermediate level of English and one other local language, preferably Luganda.

Behavioral / Attitude Competencies:

• Respect for others
• Sociable
• Leadership
• Result oriented
• Open and Decisive.
• Business Acumen
• Teamwork
• Responsible
• and assertive.

How to Apply:

All suitably qualified and interested candidates should submit their applications with updated CVs via email to apdlug.careers@abacuspharma.com

Deadline: 30^th June 2024 by 5:00pm

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