CV, British based Pakistani Quality Professional targets Middle East

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Serial No: 18764

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Skills keywords: auditing, iso 9001:2000, lean six sigma, trackwise, value stream mapping

Short Bio:

• 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
Looking for a new oppertunity in order to have global experience.

Current location:  England, United Kingdom - View on map

Nationality: Pakistani

Preferred Sector of Employment:  Pharmaceutical and Science, education and training, Manufacturing and Operations

Spoken languages: english

Location I am interested in working: Anywhere

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.