Nicola Constantinides

• Writing and updating of Standard Operating Procedures. Ensuring all SOP’s are updated according to a schedule.
• Ensure that at least one executed batch record per product is reviewed annually as part of the QA release process. Ensure that the batch documents reviewed communicates the correct formulation, method of manufacturing, artwork material and registered sites as per current approved dossier. Ensure that the approved manufacturer of the API was used.
• •Preparation of a detailed monthly report to capture all quality related activities.
• Manage the relevant permit applications and Custom’s clearance forms and complete the SAHPRA annual return for Specified Schedule 5’s and Schedule 6 Substances on time.
• Implement and maintain the necessary Quality Systems and ensure that SOP's are guiding all personnel in a clear and understandable manner.
• Communicate in a timely fashion, all information regarding formulation changes, project status, results, etc. to all appropriate individuals (QA, RA, Marketing, Supply Chain, EXCO etc.).
• Support the Responsible Pharmacist during product recalls and ensure that one Mock Recalls are performed per year (in the absence of an actual recall).
• Ensure that the QA SharePoint site is maintained appropriately in good order, and that all local trackers (where applicable) are always updated and kept current for accurate reporting.
• Act as the local VEEVA Administrator for South Africa and arrange training for all local users. ( Veeva Business Admin).
• Represent the Quality Department as part of a cross functional team to ensure the delivery of projects (e.g. product launches etc.) into production with the highest level of quality, compliance, and adherence to timelines
• Always apply Risk Management principles in the QA department and maintain a risk register.
• Ensure that at least one Quality Management Review Meeting is performed per year.
• Implement and maintain the necessary Quality Systems and ensure that SOP's are guiding all personnel in a clear and understandable manner.
• Lead technology transfers of all iNova products when needed.
• Ensure that Product Quality Reviews are available and completed per annum as per schedule. Compiling of our own local PQR’s.
• Ensure that analytical methods are validated as per GLP requirements.
• Ensure that test method transfers/verifications/cross-overs are performed for all products that are tested post-importation in South Africa.
• Participate in process improvement and product investigations.
• Manage and roll-out stability programs per product, per annum, and confirm that our products are stable throughout the approved shelf life.
• Implement the required corrective and preventative actions (CAPA), conduct the necessary quality/technical investigations and ensure that all QA/technical related matters are solved in a timely manner.
• Ensure that all CAPA’s raised out of an external audit are managed according to the time frames allocated to them.
• Conduct Change Management meetings monthly.
• Manage all Deviations (both internal and from external suppliers) as per approved processes.
• Manage and record all technical product quality complaints (PQC’s) or queries and customer returns, with the relevant stakeholders. Complaints to be trended to identify recurring issues or ineffective CAPA’s
• Manage the local GMP Audit program and conduct external audits and self- inspections as per the GMP Audit Schedule, to ensure that systems are in place to maintain the positive GMP status of all sites. Also oversee that global audits are performed by the Group QA team as per Audit Schedule, and that audit reports and responses are shared with South Africa.
• Ensure that Quality Technical Agreements are in place for all sites utilized for iNova products, and that these are maintained as per revision register.
• Manage the iNova Change Control process and facilitate and capture all change controls and communicate to all the relevant stakeholders. Manage and implement the Change Control software system (Veeva Electronic Document Management System).
• Manage all final product manufacturers (local and via the regional office), final product release laboratories, packers, warehouses and distributors of iNova products, and confirm that they have quality systems in place to ensure high quality products.
• Ensure that all manufacturers, laboratories, packers, warehouses and distributors of iNova products have the necessary GMP Certificates, Manufacturing Licenses and Site Master Files in place.
• Ensure during the QA release process that the COA’s are in line with the registered product specifications. Work very closely with the Regulatory Affairs team to ensure that products released are in line with current registered parameters, especially when there have been recent changes to registered information.
• Ensure QA release of products as per the QA Release SOP, clearly stating the release as per the QA Release Masters. Responsible to ensure that only quality products are released in to the market.
• Assume all the responsibilities of the RP in the absence of the RP.
• Application of export permits for exporting of S5 drugs.
• To ensure that all analytical OOS reports from the EMO’s are reviewed through evaluating the root cause, risk and CAPA adequacy.
• Manage, always maintain and enhance the iNova South Africa Quality Management System to be SAHPRA inspection-ready.
• Supplier Qualification.

• Manage all Deviations (both internal and from external suppliers) as per approved processes.

• Manage and record all technical product quality complaints (PQC’s) or queries and customer returns, with the relevant stakeholders. Complaints to be trended to identify recurring issues or ineffective CAPA’s

• Ensure annual stability for all Litha’s products

• Facilitating and capturing change controls

• Revision and preparations of SOP’s

• Ensure that Product Quality Reviews are available and completed per annum as per schedule.

• Product Releases - Ensure during the QA release process that the COA’s are in line with the registered product specifications. Work very closely with the Regulatory Affairs team to ensure that products released are in line with current registered parameters, especially when there have been recent changes to registered information.

• Assist with the conduction of external audits to ensure that systems are in place to

maintain the positive GMP status of all manufacturers, laboratories, warehouses and distributors.

• Performing Quality risk management/assessment on products, processes, etc.

• Ensuring availability of reference standards to laboratories

• Checking and signing off packaging material and artwork

• Ensuring GMP compliance of manufacturers, laboratories, packaging material suppliers, and distributor.

• Tutorship of post basic pharmacist assistants.

• Dispensing retail prescriptions using the Unisolv Dispensing Program

• Participation in regular in-service training sessions - these include new/recently launched products or existing products – to enhance our knowledge and help us better understand their mechanism of action.

• Ordering and maintenance, including stock rotation, of Schedule 6 drugs, and the balancing of the S6 register.

• Supervision of pharmacy interns and pharmacist assistants in the dispensing environment.

• Assist with all aspects of ethical stock including ordering of stock, maintaining dedicated stock areas organization and expiry dates, conducting cyclical and full stock takes.

• Administered wide range of immunization and contraception options in alignment with individual needs.
• Assisted patients with over-the-counter medication recommendations and responded to questions concerning drug interactions.
• Performed technical processes required to dispense medications to patients.
• Counseled customers on medications, appropriate dosage and potential side effects.
• Assisted with the maintenance and replenishment of the after hours emergency stock.
• Adherence to policies and procedures governing pharmacy practice in the public sector.

• Dispensing retail prescriptions using Unisolv.

• Adherence to standard operating procedures and pharmacy practice.

• Assisting with cyclical stock take

• Patient counselling