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 Groups 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:

Provide QA Division with administrative support

MAIN DUTIES:

Quality Management System (QMS):

• Generating (Typing) and making corrections on QMS related documents i.e. SOPs/ policies/Technical Agreements and registers
• Distribution of QMS documents internally and from both manufacturing and distribution sites
• Retrieving of archived/stored documents internally and from both manufacturing and distribution sites
• Typing and assist with preparation of QMS related presentations
• Assist with coordination during the Quality Review meetings or other QMS related meetings
• Maintain all Technical Agreements on sharepoint portal / I Drive

Data Logger Management:

• Daily checks of temperature readings within the Reference Sample rooms and escalation of any Out-of-specification results to QA Management.
• Monthly download of temperature readings of the Reference Sample rooms for Pharmacist review and approval.
• Logging and Tracking data logger information in the relevant databases.
• Downloading of data loggers received with shipments and saving it in the relevant folders.
• Where required, returning of data logger to the manufacture for downloading.
• Logging of all Temperature Excursions on the relevant database.
• Assisting with queries, where applicable.
• Preparing expired data loggers for recycling and or destruction

SAMPLES REQUESTS AND RETENTION MANAGEMENT

• Request samples required for batch review and PIT testing from the relevant Aspen warehouse.
• Monitor progress of sample receipt and highlight any delays to the relevant warehouse personnel and QA team members.
• Keep track of time taken to receive samples from the warehouses, highlight this to the relevant teams and assist in finding solutions to ensure quicker turnaround time for sample receipt.
• Ensure samples are correctly stored, easily retrievable and available for review during release process.
• Ensure that relevant courier parcels are sent off timeously and to the correct address.
• Liaise with Courier Company on details of delivery.
• Address any delays in delivery of parcels with Courier Company.
• Prepare Retention samples for Destruction.

MAINTENANCE OF ELECTRONIC QA FOLDERS AND SPREADSHEETS

• Save product information (e.g.COA / PIT) received on the relevant QA folders.
• Update the daily block list with regards to progress of products in QA awaiting release.
• Capture all data from COA and PIT on the APQR tracker.

GMP COMPLIANCE

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

General

• Ensure easy retrieval of correct documents during audits (both internal and external).
• Archiving of all Quality related documents
• File validation ensuring that before a document is submitted that all files have been checked and are correct.
• Support the department administratively to ensure compliance to regulatory authorities
• Inform/Report both to the QMS officer/QA Pharmacist of any document control related problems that may affect document control efficiency.
• Assist QA department with maintenance of quality related documents
• Perform other administrative functions as delegated by QA Pharmacist, Departmental Head or designee
• Manage and maintain departmental manual and electronic filing systems.
• Process all financial transactions for the department.
• Provide telephonic support for the QA Complaints hotline.
• Generation of statistical graphs for monthly reporting purposes.
• Organization of workshops, internal and external meetings, conferences and training sessions

EDUCATION & EXPERIENCE:

• Matric
• Tertiary Diploma (administration, customer service etc.)
• 2-3 years experience in an customer service environment;
• 2 - 3 years Pharmaceutical Industry experience In Medical or Regulatory department
• Experience with product quality complaints

SKILLS & ATTRIBUTES:

Judgement; Conflict resolution; Time management; Problem solving; Listening skills; Service Orientation; Decision making; Computer literacy; Communication; Report writing; Accuracy; Tenacity; Initiative; Empathy; Customer focused; Interpersonal sensitivity; Patience; Logical thinking; Information seeking; Cultural sensitivity

KNOWLEDGE OF:

Processes; Job knowledge (Job model); Policy and procedure; Finance; System; Product

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 14 February 2024. 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

Aspen Pharmacare