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 pharmaceutical functions within the Release sub-department of the QA department. This involves review and release of products according to GxP and company Standard Operating Procedures. KEY RESPONSIBILITIES GENERAL OPERATIONAL ACTIVITIES

• Execute daily tasks and work instructions according to the relevant SOP's.
• Operate computer systems by capturing data, printing standard reports, etc.
• Perform reconciliations of data
• Update and maintain databases
• Edit and format SOP's as and when required.
• 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 tasks reiating to your work as and when required

FINAL RELEASE OF ALL EXTERNAL SUPPLY PRODUCTS

• Review of batch documentation, i.e. Executed batch documents, Post-lmportation test results, ete. for compliance to GMP and master documents as per product dossier.
• Review of product samples and artwork, where applicable for SA Markets.
• Ensure that Post lmportation Testing (PIT) (where applicable) is being adequately managed.
• Monitoring blocked stock at the different warehouses on continuous basis.
• Ensure product release is conducted as per SOP for SA and lnternational Markets.
• Management of product re-works according to SOP and cGMP.
• Review of data logger downloads for product's received in country
• Ensure batch release by OTIF commitment dates.

INVESTIGATING AND RESOLVING QA QUERIES

• Conduct and request feedback and/or reports on QA queries from Manufacturer and discuss with QA Management team.
• Follow up on outstanding documentation such as reports and deviations.
• Approval of deviations and logging deviations received from CM in consultation with QA management team
• Management of laboratory Out of Specifications in consultation with the lab and CM
• Handling of Suspect Stock Notifications from the Aspen / 3PL warehouses to ensure they are investigated correctly and do not recur.
• Review of temperature excursions for products during transportation or storage from manufacturer, distributors, or customers in consultation with QA Management team.
• Review of raw materials status at the CM in terms of expiry date, re-testing, ete. as per SOP and assisting in resolving any queries regarding RM's
• Updating of SAP system with regards to expiry date of stock, where applicable.

CONTROL OF HIGHLY SCHEDULED SUBSTANCES

• Completion of 56 requisitions for samples requested.
• Logging of samples received in the 56 register.
• Balance of 56 Register as per Medicines Control Council (MCC) / SAHPRA requirements.
• Applying for Import permits/authorisation for all Schedule S and 6 medicines handled by the External Supply (ES) department for the SA market.
• ldentifying new products to be launched that will require a permit and performing the necessary set-up with the SAHPRA.
• Conducting regular meetings with the Commercial / Demand Planning department to ensure that all 55 and 56 medicines coming into SA have permits.
• Ensuring that the permits are customs cleared once the product is in country, performing the necessary reconciliation and sending the permits back to SAHPRA / MCC as per agreed timelines.

MANAGEMENT OF QA ACTIVITIES FOR NEW PRODUCT LAUNCHES AND RE-ALIGNMENTS

• Requesting Finished Product Testing documents from Regulatory Authority (RA) department and providing these to the potential PIT labs for quotation.
• Assisting in resolving any queries arising with PIT lab and RA / Aspen technical team.
• Reviewing the PIT quotations from the labs and advising the QA manager as to the most appropriate option.
• Co-ordinating the Analytical Method Transfer (AMT) with the selected PIT laboratory for New product launches and re-alignments, where required.
• Oversee that the Reference standards, Columns, and other materials needed by the PIT lab are ordered timeously to prevent delays in testing of new launch products.
• Ensuring the master documents and executed documents are requested and received timeously from the supplier as part of the launch/re-alignment process.
• Review of the full batch documentations for the 1st two batches of a new product launch or re-alignment for compliance to GMP and product dossier.

QMS METRICS - SOP's, DEVIATIONS & CHANGE CONTROLS AND REPORTING

• lnitiation and review of SOPs relevant to work function.
• Completion of the sections in the QSMR relevant to batch release and lab management.
• Logging of internal deviations on the QAlign system and management thereof to ensure that adequate CAPA's are in place to prevent future recurrence on non performances.
• Review of external deviations and making recommendations as to actions to be taken.
• Completion of action items assigned on Change Control on QAlign system.
• Performing internal audits as and when required.
• Compiling AD-hoc reports as and when required

CONTINUOUS IMPROVEMENT INITIATIVES

• Identify gaps within the current processes and investigate and propose ways to close those gaps
• Identifying ways to streamline processes, resulting in quicker turnaround of QA activities.
• Manage projects assigned to you as per guidelines from the manager and as per agreed timeframes.
• Regularly provide feedback on progress of projects and highlight any issues that require manager's attention.

HUMAN RESOURCES

• Compliance to Labour Legislations and ln-house Best Practice).
• Familiarize 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 ENVIRONMENTAL STANDARD

• Carry out any duty or requirement imposed on the company by the OHS Act and in accordance with your specific SHE appointment.
• Report any unsafe or unhealthy situations to SHE representative or Line Manager
• Report any incident to the SHE representative or Line Manager which may affect your health or cause injury

EDUCATION & EXPERIENCE

• Matric/Grade 12
• Bachelor in Pharmacy
• Registration with South African Pharmacy Council {SAPC)
• Computer Literate - MS Word & Excel
• 1-2 year experience in Pharmaceutical environment
• Pharmaceutical Manufacturing experience

KNOWLEDGE:

• Sound knowledge of Good Manufacturing Practice
• Strong working knowledge of pharmaceutical manufacturing
• Pharmaceutical standards and compliance requirements
• People management
• Ability to interpret and implement policies, processes and objectives
• Good Documentation Practices

SKILLS AND ATTRIBUTES:

• Good verbal and written communication skills
• Professional presentation
• Time Management
• Ability to multitaskand strong proven follow-up skills is a requirement
• Planning and organizing skills
• Good interpersonal skills
• Problem solving/analytical skills
• Interrogating Information
• Customer Focused and Production
• Finalising output
• Accuracy& Tenacity
• Can do attitude
• Motivated, flexible and able to work within a team-orientated environment
• Ability to follow instructions
• Trustworthy
• Ability to work under pressure
• Attention to detail
• Managing Performance

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.