Job Description

Company Description

We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversi?ed by geography, product and manufacturing capability. Aspen is a dynamic organisation built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At aspen, not only do we source for the best talent but we also provide a host of opportunities for continuous development. The Groupxe2x80x99s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines. Objective: To perform the compilation and review of Product Quality Reviews (PQR's) for the QA department. KEY RESPONSIBILITIES GENERAL OPERATIONAL ACTIVITIES

• Execute daily tasks and work instructions according to the relevant SOP's.
• Update and maintain databases.
• Generate reports as per instruction.
• Verify and interpret the accuracy of data and audit documentation.
• Ensure that all relevant documentation gains the necessary signatures for completion.
• Maintain accurate filing and retrieval of documentation.
• Perform any other administrative tasks relating to your work as and when required.

PRODUCT QUALITY REVIEWS

• Compiling PQR schedule based on risk assessment.
• When required, compile PQR reports based on raw data provided by the manufacturer.
• Review PQR reports compiled by Admin Co-ordinator or Pharmacist Assistant for accuracy and compliance to dossier, Technical Agreement and GMP requirements.
• Reviewing PQR reports provided by manufacturer for accuracy, compliance to dossier, Technical Agreement and GMP
• Identifying risks arising from PQR reviews, escalating to management, and performing risk assessments where required.
• Ensure that appropriate CAPA's are identified from PQR reviews, and the relevant department is notified to implement and ensure an Effectiveness check is performed.
• Propose and developed methods for improving PQR's.

REPORTING AND QUALITY SYSTEMS

• Compiling of Monthly Departmental Report
• Compiling and Completing applicable sections QSMR
• Compiling AD-HOC reports as required
• Compiling and reviewing SOPxe2x80x99s related to work function i.e. PQRxe2x80x99s.
• Performing training on relevant SOPxe2x80x99S related to work functions where required
• Log and manage required actions / records in electronic QMS.

RECALLS, BLOCKED STOCK REPORTS

• Manage recalls, collation of information, and communication ta the relevant involved parties.
• Manage blocked stock situations
• Conduct mock recalls as per schedule and SOP

HUMAN RESOURCES

• Compliance to labour legislation and inhouse best practise.
• Familiarising yourself with and at all times act in accordance with the company policies and procedures.

GMP COMPLIANCE

• Complete all records and reports timeously and accurately as described in the relevant SOP's, protocols and associated documentation.
• Comply with GMP/GLP requirements as outlined by company SOP's and written instructions in all tasks and activities.
• Ensure that products are handled according to the required SOP's and documentation.

HEALTH, SAFETY AND ENVIROMENTAL STANDARD

• Report any unsafe or unhealthy situations to SHE representative or Une Manager
• Report any incident to the SHE representative or Une Manager which may affect your health or cause injury

EDUCATION & EXPERIENCE

• Grade 12 / Matric
• Bachelor in Pharmacy
• Registration with South African Pharmacy Council (SAPC)
• Minimum 1-2 yearsxe2x80x99 related work experience
• Pharmaceutical manufacturing experience
• Computer Literate - MS Word & Excel

COMPETENCIES AND KNOWLEDGE

• Accuracy & Tenacity
• Analytical mind
• Interrogating Information
• Managing Performance
• Can do attitude
• Motivated, flexible and able to work within a team-orientated environment
• Self-driven and takes initiative
• Displays Personal Responsibility
• Ability to follow instructions
• Sound knowledge of Good Manufacturing Practice and Good Documentation Practices
• Finalising Output
• Customer Service

SKILLS AND KNOWLEDGE

• Strong working knowledge of pharmaceutical manufacturing
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives
• Good verbal and written communication skills
• Good report writing skills
• Professional presentation
• Time Management
• Ability to multi task and strong follow up skills
• Planning and organizing skills
• Good interpersonal skills

Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 10 October 2023. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate.

If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.

Internal Applications must be completed using an Aspen mailing address, after applicants have informed their direct line managers of their application.