Employment Experience
May-2013 to Date: AstraZeneca – QA Logistic Support Officer
• Conducting inspection ,sampling or testing for certified, part certified components and starting materials.
• Maintenance of master data/specifications in ICON(SAP) and LinX(Lab Management System).
• Involved in Pivotal role during VSM (Value Stream Mapping) in 2012 led to achieve Mac award.
• Managing STOP card and Risk assessment as SHE Representative.
• To raise Lab investigation and its investigation to establish root cause.
• Provision of non-standard Certificates of Analysis(C of As).
• Complete all the aspects of archiving for Macclesfield Operations on site or via external liaison.
• Proactively look for opportunities to identify change and make efficiency savings whilst ensuring an appropriate level of compliance.
• Completed IOSH course to become SHE Representative in Aviation premises warehouse.
• Managing destruction of rejected materials.
• Collaboratively working with staff and manager to identify improvements and training gaps.
• To raise customer complaint and its investigation.
• To perform sterile sampling (Goserelin) in biological safety cabinet.
• Collaboratively coordinate with Zoladex plant to priorities zoladex resample request and its releases.
• Ensure local readiness for internal and external audits and inspections.
• Contribute to the resolution of QNs(Quality Notification) and LIs(Lab Investigation).
• Supervising PDCA weekly meeting to ensure on time release of API and Packaging components.
• To perform weekly and monthly calibration for GMP critical instruments in lab.
• Perform self-inspection periodically to Archive department and Warehouse-1.
• Managing site archive via TRIM database management system.
Jul-2011 to Apr-2013: AstraZeneca – QA Packaging Officer
• Monitoring of line GMP performance and completion of GMP tasks and support Checks throughout orders of batch documentation to ensure GMP compliance.
• Support for interventions procedures and non-routine activity e.g. IQ/OQ for a change control or rework Support.
• Assessment of batch disposition and ability to block stock in SAP ICON from further action.
• Provide appropriate hand-over to QAAs for approval of Quality Notifications.
• Regular review of Packaging Line LTO (License to operate) performance and flag up adverse trends and update QAAs on any agreed actions.
• Deliver GMP Training.
• Provision of flexible cover to mirror the production teams working patterns to provide immediate support.
• Maintain and develop own professional capability.
• Deviation investigation and follow up.
• Trained in root cause processes and able to assist with the process.
• Agree containment actions and assessment of continued manufacture Score Deviation Risk based assessments.
• Quality project involvement to ensure appropriate DQ/IQ/OQ and PQ follow and comply procedures.
• GMP coaching to production staff with regards to discrepancies.
• Participate in production, PDCA and quality meeting to discuss various quality issues and any outstanding issues.
• Periodically participation in GMP self-inspection.
Jan-2011 to Jul 2011: Catalent Pharma Solution – QA Officer
• Collation and quality review of batch documents to ensure documentation is correct and complete for batch disposition.
• Batch disposition of non-pharma finished products.
• Initiation, review and approval of unplanned deviation investigations.
• Processing of part rejections of finished product batches to enable batch release of acceptable product.
• Allocations of specific lots of starting materials and adjustment of batch quantities as required to allow for variable potency in the POMS weigh/dispense system.
• Review and approval of planned deviations in the Track wise change control work flow prior to execution and post-execution approval.
• To perform the Audit of QC test data for Pharma batches.
• Review of investigation reports, segregation reports and rogue investigation reports. Agreement and allocation of corrections in the Track wise quality system.
• Review of paperwork and processing of retail packed product batch releases.
• Represent the QA team at customer service and planning meetings.
• Act as primary quality to quality contact with key customers as required.
• Audit of processes and procedures as a member of the internal audit team.
Nov-2009 to May-2010 : GSK Pharmaceuticals – QA Specialist
• To promote high level of GXP Awareness and compliance within the UK operations.
• To provide general QA support and consultancy in regards to equipment/facilities/utilities engineering, laboratory services and GMP cleaning.
• Review/approve documentation associated with site operations services to GXP areas.
• To perform external assessments/audits of UK operations service partners/vendors to measure compliance with appropriate regulations and policies and maintain GSK approval.
• To liaise with third party service provider in gathering required information for quality assessment.
• To follow up CAPA.
• To aid investigation of quality related issues, and implement corrective actions to address.
Nov-2007 to Nov-2009: Aesica (Formerly MSD-UK) Pharmaceuticals – QA Specialist
• Run and monitor the internal audit systems to ensure compliance with cGMP and procedures.
• Participate in Vendor Approval process through Vendor Questionnaire.
• Ensure that the procedures contained within the quality system are valid and suitable through planned review.
• Provide cGMP expertise during the commissioning, validation and cleaning of the API production processes.
• Organize FDA, MSD and MHRA Audits.
• Conduct batch documentation reviews and ensure compliance.
• To approve API Batchess on SAP system.
• Review and ensure compliance of process validation documentation.
• Managing the Monthly Quality Matrix(KPI) for Whole site.
• Conduct cGMP audits of the Ponders End facilities and ensure corrective actions are addressed.
• Understand and operate the Quality aspects of SAP including vendor approval and materials release.
• Participate in daily production and planning meetings.
• Managing Change Control, CAPA, Non-Conformance and Deviation database.
Apr-2007-To Jul-07: Emergent Bio-Solution-UK – QA Scientist
• Assisting the generation of product specification files and compiling documentation for batch review & release.
• Review of drug substance, drug product and batch records to ensure GMP regulations and internal procedures are adhered to at all times.
• Assist the Quality Assurance Manager with the management of third party service providers – including the preparation of audit plans, participating in audits, writing audit reports and following up corrective actions.
• Manage quality assurance documentation in compliance with pre-defined processes.
• Perform internal audit as per schedule.
• Management of CAPA and internal audit findings, responses and deadlines.
• Participate in Annual Product review.
Achievements
• Established step by step SME(Subject Matter Expertise) change over procedure for High Speed packaging lines-PPB- Macclesfield.
• Astrazeneca Mac Award on VSM project 2012-2013.
• Help in Creating a QA inspection spreadsheet document for packing lines-PPB- Macclesfield.
• Successful article published in dawn newspaper on Menace of Drug Counterfeiting. http://archives.dawn.com/weekly/science/archive/060722/science4.htm
Qualifications
• MBA-Innovative Management from Coventry University-2009-2010
• MSc in Pharmaceutical Services and Medicines control, University of Bradford, 2004 – 2005
• Dissertation Title: Control of CGMP (Current Good Manufacturing Practices) in Pharmaceutical Industries.
• Bachelor of Pharmacy.1997-2001
Certification
• QP Certification-Module-1&2(QMS) from David Begs Associate (NSF) via AstraZeneca.
• IOSH Certification- SHE Representative to perform Risk Assessment and BOSHE.
Skills
• Leadership /supervision
• Decisive
• Excellent communication skills both verbal and written.
• Good Attention to details.
• Time keeping/Managing timely production according to plan.
• Team working and motivating a staff.
• SAP system management for Batch Approvals.
