• QC Project Lead on new Laboratory expansion with participation on cross-functional project teams (Quality & Engineering).• Generation, review and approval of all validation lifecycle documentation• Equipment Validation SME to support all regulatory/corporate inspections, internal audits and Regulatory Compliance Activities• Procurement of QC Capital expenditure items & governance of Capex Projects.• Governance & Scheduling of System periodic reviews on Pemac & generation of Periodic Review Reports in accordance with timelines. • Project lead in the Implementation of EMS/BMS to QC laboratory (sample login room, fridge, freezer & Incubator) with participation on cross-functional project team (Quality, Engineering & Validation).• Participation in the governance of QC Equipment work stream projects, scheduling and delivery of activities in accordance with timelines.• Participation in improving cross functional communication by liaising with FC in a monthly equipment forum to review & align our equipment qual processes and by participating in the monthly GSIUC equipment governance forum with Key stakeholders for cross functional alignment.• Supporting and leading of cGMP related deviations• QC System Administrator on computerised /firmware systems• Responsible for Vendor EHS induction and issuance of permits in QC• PM/CAL ,Corrective maintenance of laboratory equipment & troubleshooting• Training and mentoring of junior analysts

Areas of Responsibilities• Review of product transfer data to ensure compliance to appropriate specifications and protocols. • QC Support for site activities E.g. Cleaning Validation reports, Bulk hold studies, review of cleaning validation results.• Participation on cross-functional project team for the Implementation of Data Integrity to QC systems onsite.• Project managed the commercial training handover & commercial documentation for NPI products to the commercial team, deploying the relevant DMAIC tools to define the project (charter, process mapping and generation of standard work).• Generation & Review of Datasheets for new product introduction.• Equipment Validation SME to support all regulatory/corporate inspections, internal audits and Regulatory Compliance Activities• Execution Micro verification on NPI products• QC System Administrator on computerised /firmware systems• Generation and approval of equipment qualification lifecycle documentation including change controls, risk assessments, protocols, reports, SOPS etc.• Execution of equipment Qualifications projects e.g. HPLC, UPLC, Dissolution Systems, GC, Fridge/Freezers/Incubators, KFSGovernance & Scheduling of System periodic reviews on Pemac & & generation of Periodic Review reports in accordance with timelines.Reporting & Processing of cGMP related deviations Participation in QC Safety audits

• Writing and reviewing of SOP’s and document control.• Training and mentoring of new and junior analysts.• Involved in the timely progression of many laboratory OOS/OOT and IR’s and updating documents as required on Qumas.• Review of analysis, and documentation.• API Testing.• Finished Product Testing, which includes Appearance, Identification by HPLC, UV, Average Tablet weight, Assay, Related Compounds, Dissolution, Mass Variation, and Uniformity of Dosage Units.• Raw Material Testing (packaging and excipients).• Water Testing.• Stability Testing.• Standardisation and Re-Standardisation of Reference Standards.• Testing Swabs for cleaning validation.• In-process testing including blends, stratified samples, AQL’s (Tablets & Capsules) & release testing.• Trending of results & compiling result summary sheets.• Use of Chemstation, empower & winaspect software.• Use of HPLC, KF, FTIR, Dissolution & UV.• Dissolution pH profiling.• Co-ordinator of Environmental monitoring on site, trending of all results.

• Liquid Particulate analysis on the HIAC 9703 system• Chromatography:HPLC: Waters ;systems Setup, interpretation of chromatograms, processing data in relation to potency testing and related substances.Trouble shooting HPLC; including leaks, air bubbles, changing the frit, & performing light intensity test.GC: Agilent, preparing GC Test Methods, sample sets, project names and processing data and interpretation of chromatograms for GC Headspace.• Administration of laboratory calibrations and qualifications.• Use of Empower, Chemstation, and LIMS software.• Performance qualification of the 888 Titrando (Autotitration) system.• Use of HPLC, GC, KF, IR, UV.• Raw Material Testing.• Troubleshooting and Calibration of Analytical instruments • Provided training to new QC Personnel.• Review of analysis and documentation.• Writing and reviewing of SOP’s, worksheets, TM and document updates.• Water sampling and testing.• Lab preparation for IMB audits

• Chromatography:HPLC: Waters (empower software) systems Setup, interpretation of chromatograms, processing data in relation to potency testing and related substances of drug eluting stents.• Deployment of stents• Calibration of balances pipettes etc.• Trending of Results for potency, rel subs, BHT, Elution.• Sample receipt from QA, Preparation of Test Request forms and Preparation of Samples.• Updating Training files for QC Personnel.

• In-process & Finished product testing consisted of spectroscopy & wet chemistry analysis (sodium bicarbonate, sodium lactate, ph, sodium chloride, magnesium, calcium, calcium chloride, total chloride, dextrose and density)• Calibration and troubleshooting of Analytical instruments.• Water testing.• Worked with Ebatch software.• Lab preparation for IMB audits.• Provided training to new QC Personnel.

• Finished product/Batch release/Stability testing (HPLC, Spectroscopy, wet chemical analysis and physical analysis)• Chromatography – Reverse phase, anion exchange and Molecular Weight HPLC with use of cerity software on Agilent HPLC’S.• Preparation of Standard operating procedures, stability protocols and workbooks for new methods.• Summarization of Analytical Transfer data for new methods.• Cleaning Validation• Validation report for UV transfer method.• Troubleshooting and Calibration of Analytical instruments.• Participation in laboratory audits, self inspection and external (IMB& FDA).• Training of new QC Personnel.