Job Description:
JOB SUMMARY The Branch Pharmacist is responsible for the compliance of regulatory, statutory and quality standards by ensuring that business transactions, such as order processing, picking, quality checking, material deliveries and transfers, including pull-out of Regulated Drugs, are aligned to the government legal requirements and quality standards of the company. She is primarily responsible in the annual renewal of FDA License to Operate and PDEA License to Handle Dangerous Drugs of the Branch.
She also acts as Site Document Controller, who is responsible of the control of documents and records, in compliance with the ZP Regional Standards and ISO 9001 current version, aligned to the company’s vision, mission and directions to ensure achievement of customer fulfillment and service objectives of the company.
DUTIES AND RESPONSIBILITIES REGULATORY Handles legal licenses (LTO & LTH) renewal and ensures validity as required by the Food and Drug Administration (FDA) and Philippine Drug Enforcement Agency (PDEA). Ensures compliance of FDA, PDEA and other government authorities’ regulatory and statutory requirements. Notifies the branch manager and the company’s regulatory affairs manager in case of FDA and/or PDEA inspections/audits. Facilitate external / internal regulatory audits Gives update to the management on the results of the FDA and/or PDEA inspection/audit and discusses resolution to issues/findings if needed. Informs the management and staff on the new government rulings or regulations to keep them updated and ensure compliance. Checks, updates and maintains files of customers’ LTO and coordinates closely with the master data maintenance section to ensure that the branch transacts only to customers with valid licenses. Ensures that Dangerous Drugs are invoice only to customers with valid S-License. Maintains an updated file of customers S-licenses. Ensures that controlled copies of laws, including but not limited to, Republic Acts, Administrative Orders, and related pharmaceutical books governing the business are available in the site/branch. Records all transactions of dangerous drugs in the dangerous drugs database and prepares semi-annual report as required by law. OPERATIONS Prepares PDEA order form for Dangerous Drugs transfer requisition of the branch. Facilitates approval of customer’s PDEA order form by sending to the ZP head office regulatory pharmacist. Handles Dangerous Drugs transactions from order processing to dispatch and ensures adherence to PDEA regulations. Receives orders from different authorized sources. Stamps date/time orders once received. Checks or verifies authorized signatory of the orders received. Checks orders of dangerous drugs prior to order entry in the system Maintains/encodes the PDEA permit number, S-License and its validity in the system prior to order entry of dangerous drugs. Acts as back-up in the absence of the QA Associate for the following functions, but not limited to: Picking of dangerous drugs listed on the pickslip in cross reference to PDEA permit. Oversees checking and dispatch of dangerous drugs by submitting the stocks with the necessary documents (pickslip, invoice, PDEA Permit and Delivery Tracking Monitor) to Outbound Checker for one to one checking with the Forwarder. Handles trade returns of dangerous drugs from pull out up to turn-over to destruction warehouse and ensure that these are covered with a valid PDEA permit. Ensures monitoring and control of access in the Regulated (ACRD) Storage area. Reports immediately to Supervisor or Asst. Warehouse Manager any dangerous drugs discrepancy discovered during picking, checking and/or physical inventory count, and prepares corresponding incident report to Philippine Drug Enforcement Agency (PDEA) for proper action and disposition. Files all documents related to regulated drug transactions and maintain quality records based on retention period. DOCUMENT CONTROL Acts as local document controller of the branch and in close coordination with the Site QA, Head Office Document Controller and Distribution’s Document Administrator. Ensures that all procedures and support documentation related to the branch IQMS are properly reviewed and approved by the authorized signatories and proper training is provided before these are issued for implementation by the section concerned. Oversees the creation, processing, review and approval, issuance and distribution, recall/retrieval, retention/archiving and disposal of controlled documents in accordance with the established documentation requirements of the Integrated Quality Management System. Recommends/Initiates timely revisions, review and/or preparation of documented procedures. Routes Document Change Notice (DCN) to all key personnel/process owners as indicated on the approved DCN. Routes finalized/revised document to all approving authorities and distributes revised/newly approved documents to Copyholders. Ensures that Master List of Documents, Records and Forms are kept updated. Handles training / cascading of documents that she authors or attended training thereof. Handles projects pertaining to control of documents and records. Handles and oversee the upkeep and maintenance of the Archives of the site. Proposes policies and procedures for the improvements of the control of documents and records and its archive. SAFETY AND QUALITY COMPLIANCE Acts as Quality point person in the branch. Shall be responsible for QA-verification and QA release on quality related checks performed by Operations group. Ensures that all activities in the office and warehouse are in compliance with established ISO standards, cGMP, GSDP and Regional QA standards. Ensures that the following activities are implemented in all the quality processes of the branch. Physical checking of the quality of stocks. Ensures that the stocks are pest free. Checks the labels to ensure that these are not for “physician’s sample” Checks the actual labels to tally with the description on appropriate records. Checks temperature of cold chain stocks upon receipt, storage and dispatch. Ensures that storage temperature of stocks is met. Conducts internal audit inspections for GSDP/ISO compliance in preparation for clients and other external audits. Ensures that all activities are performed in accordance with the Standard Operating Procedures (SOP) as indicated in the Quality Manual. Takes responsibility of Pharmacovigilance monitoring on-site. Conducts training to enhance awareness on Pharmacovigilance concepts and components Attends to all internal and external audits concerning control of documents and records. Performs duties and responsibilities in accordance to safety and health guidelines, company rules and regulations, legal requirements and quality standards. Attends quality and safety related trainings, such as, but not limited to GSDP, cGMP, ISO, ERT, Basic Occupational Health and Safety standards scheduled by management. Observes cleanliness and orderliness of assigned activity area at all times. Adheres to company rules and regulations and safety guidelines at work all times. Minimum Qualifications:
Graduate of Bachelor of Science in Pharmacy and have passed the Pharmacy board examination Proficient in oral and written communication Knowledge in SAP-ECC & EWM Excellent awareness on GSDP, 9001:2008 and other quality standards Knowledge on basic computer applications Familiarity with relevant government agency regulations Ability to operate in a fast-paced environment and able to meet deadlines with multiple competing priorities
