ISRA YASEEN

• Proficient in the usage of LIMS (Laboratory Information Management System).
• To perform Identification of different micro-organisms such as Listeria, Salmonella, Staph, Bacillus, Clostridium, Campylobacter using different techniques such as gram staining API identification, Coagulase test etc.
• Analyze and interpret laboratory results, preparing detailed reports of findings for clients or regulatory authorities..
• To perform when required preparation and analysis of food and swab samples in accordance with valid methods.
• To maintain and propose several ideas to maintain quality of lab.
• To perform Analysis of microbiology test samples for Microbial count (Yeast, molds, aerobes, anaerobes)
• To supervise lab, assign tasks and delegate responsibilities to technicians in the absence of Team Leader.
• Conducted Polymerase Chain Reaction (PCR) analysis on pickstock and pooled samples for the detection of Salmonella.
• Operate and maintain laboratory equipment such as incubators, autoclaves, and PCR machines.
• Performed quality checks for routine analysis and for the approval of laboratory results
• Collaborated with multidisciplinary teams for successful assignment completion.
• Maintained meticulous records with detailed documentation of experimental data and findings following GdocP.
• Maintained 5S to main lab more organized and productive.
• Spearheaded quality control measures to uphold industry standards.
• Streamlined laboratory procedures, enhancing operational productivity.

• Provided excellent customer service in a fast-paced environment
• Managed inventory and ensured product availability.
• Maintained store cleanliness and organization of stock.
• Handled transactions accurately and efficiently.
• Assisted with stocking shelves and managing product displays.
• Ensured smooth store operations during busy hours..

• Accurate dispensing of prescriptions under the supervision of a qualified pharmacist, ensuring compliance with legal and ethical guidelines.
• Proscript Connect: Proficient in usage of Proscript software.
• Daily Ordering: Ensured ordering for regular Customers on daily Basis, Took initiatives to smoothen the process.
• Customer Service: Provide excellent customer service, addressing inquiries and offering professional advice on over-the-counter medications and healthcare products.
• Blister Packs: Managed Blister Packs individually from ordering script to stock and making blister packs error free.
• Stock Management: Manage pharmacy stock levels, ensuring proper storage and expiry date monitoring. Assist in regular stock checks and replenishment.
• Record Keeping: Maintain accurate and up-to-date records of prescription dispensing, patient details, and other relevant documentation in accordance with pharmacy regulations.
• Health Promotion: Support the promotion of public health initiatives, such as flu vaccinations, Covid Jabs.
• Team Collaboration: Work collaboratively with pharmacists and other team members to ensure efficient and smooth pharmacy operations.

• Conduct routine environmental monitoring for microbial contamination in the manufacturing facility, including air, water, surfaces, and equipment. Document findings and ensure corrective actions are recorded and implemented when necessary
• Managed procurement of laboratory consumables, equipment, and services (OPEX & CAPEX), ensuring cost-effectiveness, regulatory compliance, and timely delivery while maintaining strong vendor relationships.
• Ensured the implementation of up-to-date working methods and adherence to relevant pharmacopoeias. Ensure that all microbiological testing and documentation comply with regulatory agencies such as the FDA, European Pharmacopoeia, and other relevant authorities. Support audits and inspections by preparing and providing necessary documentation and data.
• Performed vendor qualification to ensure compliance with quality standards, regulatory requirements, and contractual agreements
• Conducted growth promotion testing for bacteria, yeast, and molds.
• Performed water testing (Water for Injection, Distilled Water, Waster Water) and designed trend analysis.
• Proactive participation in meetings and helped create new practices
• Consistently met my short and long-term targets
• Coaching, and mentoring employees in their areas of responsibility
• Interface with Divisions, Quality Assurance, Manufacturing, Engineering and Purchase dpt
• Leading role in troubleshooting/investigating technical and procedural issues.
• Active member of the Operational Excellence (OE) team, contributing several ideas for process improvements and efficiency enhancements.
• Managed the submission of CTD (Common Technical Documents) of Drugs to DRAP (Drug Regulatory of Pakistan).

Microbiological Testing Lab

• Ensured the completion of internal and external audits, including those from local government and international regulatory bodies, with successful outcomes.
• Ensure that all procurement activities are conducted within the allocated OPEX and CAPEX budgets. Regularly track and report on expenditures to ensure that financial targets are met. Assist in forecasting and planning for future procurement needs based on lab requirements and project timelines.
• Oversaw the procurement of laboratory consumables, equipment, and services (OPEX & CAPEX), ensuring cost efficiency, regulatory compliance, timely delivery, and fostering strong vendor relationships
• Creation, review, and revision of microbiological Standard Operating Procedures (SOPs) and other relevant documentation to ensure compliance with industry regulations and best practices.
• Maintain records for calibration, maintenance, and qualification of microbiological testing equipment to ensure it is in proper working order and compliant with GMP standards.
• Ensured the integrity of all microbiological data through proper documentation practices, including timely entry, accurate record-keeping, and adherence to data retention policies.
• Ensuring that adequate and updated working methods and Pharmacopoeias implementation
• Performance of Sterility Testing, bioburden and Endotoxin testing of Parenteral Products, Designing and updating trend
• Performed Gram staining and API identification for microbial analysis.
• Cultivated and maintained ATCC strains for microbiological analysis and testing.
• Performed growth promotion of Bacteria, yeast and mould.
• Conducted water testing (Water for Injection, Distilled Water, Waste Water) and developed trend analysis models.
• Performed media fill testing, validation of instruments (including autoclaves and incubators), and conducted equipment qualifications
• Conducted testing of raw materials and finished products, including solid, semisolid, and parenteral forms
• Proactive participation in meetings and helped create new practices
• Consistently met my short and long-term targets
• Coaching, and mentoring employees in their areas of responsibility
• Interface with Divisions, Quality Assurance, Manufacturing, Engineering and Purchase dpt
• To ensure timelines of Activities
• Leading role in troubleshooting/investigating technical and procedural issues
• Managed deviations (OOS, OOT) and proposed corrective and preventive actions (CAPA) to address non-conformities, follow up of Implementation of Corrective action.
• Managed change control processes, including entering changes into systems, obtaining approvals, updating SOPs and relevant documents, and closing change management in the system

Validations

• Conducted training sessions on QC protocols, contributing significantly to staff competence and adherence to standards.
• Hold time study of Dehydrated Medias
• Hold time study of Reagents/Sterilized items used in the Microbiological testing lab (Protocol, Execution and Report Compilation)
• Validation study of API kits used to identify micro-organism (Protocol, Execution, and Report compilation)
• Effect of Heat Treatment on Micro-organism (Protocol, Execution, Documentation and Report compilation)
• Verification of effectiveness of sterilization and depyrogenation of empty ampoules by dry heat (Protocol, Execution, Documentation and Report compilation)

Qualifications

• Site Acceptance Test of Sterilizers
• Installation Qualification, Operational Qualification and Performance Qualifications of Sterilizer (Nebula 250 SDS R Make: Last Technology AND Systec)
• Assistance in the Qualification of Cleanrooms (A, B, C, D).

Analytical Testing Lab

• Proficient in SAP logon
• To support the continuous development of wider QC operations and continuous improvement programs
• Ensured QC equipment and systems are maintained / calibrated / qualified to appropriate standards
• Pitched ideas on how to improve performance and efficiency
• Complete Anlytical testing of Auxiliary (Raw Material) following pharmacopoeias
• Assay of auxiliaries and finished Products
• BOD, COD of Wastewater
• Performed TOC of WFI and Purified Water
• Expertise in various analytical Instruments (HPLC, GC, FTIR, Karl Fischer, Potentiometer, Penetrometer, OptiMelt, Dropping Point Apparatus, Density Meter)
• Participated in troubleshooting/investigating technical and procedural issues.
• Collaborated with cross-functional teams to improve overall product quality.
• Improved staff knowledge on QC matters through regular training workshops leading to enhanced performance.
• Streamlined production processes, yielding higher quality outputs.
• Participated actively in regular audits which kept us aligned with international standards.
• Improved safety measures within the manufacturing plant by conducting regular risk assessments.