Looking after the Quality Assurance, Regulatory and Quality Control functions, which include; Routine testing of the material and finished product, stability, related documentation, SOPs (preparation and management), qualification (area, machine, system), Product registration, Yearly plans/calenders for calibration and validation Inspection and Audits etc

Looking after the following functions in QC-Finished Goods testing-Stability studies-Validations-New product testing (analytical section)- National and international Regulatory documentation (QC Part)-ISO-17025:2017 implementation and audit.

Core responsibilities areQC oversight for compliance and integrity

 Sampling of API raw materials, API intermediates, APIs, starting materials packaging materials, bulk drug products and finished drug products according to approved sampling plans. Testing of the above listed materials according to approved and validated test methods. Sampling and testing related to utilities, equipment used for the manufacture of Products. Participation in creating deviation or OOS/OOT reports in case of testing issues. Ensure that any changes that have the potential to impact upon quality, safety or effectiveness, and deviations from approved instructions and procedures in Quality Control are recorded and investigated. Ensure that the analytical equipment is qualified, maintained and calibrated. Testing of validation. Testing of in-process samples.  Check of the maintenance of the department, premises and equipment. Validate/verify analytical test procedures. Participation in the Initiation of stability studies, issue Product Stability Alerts to QA.  Maintain Reference Standards (primary and secondary) Ensure that QC raw data is maintained. Management of chemical reagent inventory. Manage retention sample. Provide support for preparation of product quality reviews. Participation in the investigation of complaints, deviations, discrepancies etc. related to the quality of the product as well as counterfeit issues

 Compilation of executed batch records, executed laboratory control records Production control records, and associated (executed) records Release of batch record for: Repacking and relabeling  For the distribution in Market. Assurance that manufacturing processes and analytical methods are validated as well as review and approval of qualification and validation protocols and reports. Assurance that the batches have been produced in compliance with the marketing authorization and GMP requirements Assurance of the correct labeling of containers of materials and products. Evaluation of deviations. Notification of the company’s responsible person in case of recalls, reports and any observations. Evaluation of changes related to products, processes, procedures, equipment and facilities that have the potential to impact upon the quality, safety or effectiveness of products. Reviewing GMP-relevant documentation e.g. SOPs sampling and testing protocols, Master Batch Records and executed Batch Records. Assurance that equipment is qualified and are validated as well as review of qualification and validation protocols and reports. Coordinate GMP Training Program Assuring that in case of discrepancies investigations are made to determine the cause and corrective actions are defined.

ROUTINE ANALYSISANALYTICAL METHOD VALIDATIONANALYTICAL INSTRUMENTS CALIBRATION