QA Compliance Pharmacist(4 months contract) - Port Elizabeth at Aspen Pharma Group

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

Requirements

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