Irfan Ali Zeb Email & Phone Number

Jeddah, Makkah, Saudi Arabia

Karāchi, Sindh, Pakistan

1) Leading the project on installation of RABS in 2 sterile plants,2) Successfully deployed electronic documentation system for the entire site as per 21CFR part11, 3) Established Contamination Control Strategy for manufacturing operations at sterile plants, 4) Enhanced quality in the manufacturing documents on floor5) Successfully obtained DRAP approval for the 4 manufacturing plants of the site, 6) Playing active role in the global microbiology platform.7) Initiated 2 platform in global Sanofi media i.e. Google Glass, Microbiology

Karachi

• Manage and monitor implementation of Sanofi global Quality Standards at site.• Review and approval of qualification and validation protocols and reports.• Successfully upgraded the GMP documentation in the light of Sanofi global requirements.• Manage the functions of QA operations in the absence of QA Head.• Manage the comprehensive GxP training across the site through need analysis, role profiling, trainer’s certification and training plan.• Provide technical support in aseptic facility, water systems and HVAC system.• Manage Complaint, Change Control, CAPA and Deviation.• Plan and manage internal audit and self-inspection. Manage site audits by third parties.

• Successfully achieved highest level of Quality Manual Implementation across Novartis OTC Division in 2013. • Successfully managed timely completion of Site Quality Risk Assessment (SQRA), High Level Product Assessment (HLPA) and Contract Manufacturing Quality Risk Assessment (CMQRA) of Third Party Organizations with Identified gaps and action for improvements.• Support Compliance function in ensuring cGMP Compliance of all operations through auditing, training and CAPA management.• Establish Site Quality Plan at Jamshoro site. • Established action plans on site audits by GCA and Regulatory authorities.• Represent Jamshoro site in a number of regional and global QA platforms.• Manage plant-wide Validation / Qualification activities as per Novartis Quality Standards.• Manage product quality assessment and continual improvement through Annual Product Quality Reviews.

Joined the company as a Quality Assurance Manager and worked up the hierarchy to merit promotion to the position of Quality Manager.Highlights:• Bestowed with best Quality improvement award in 2009 from UK Headquarters while competing against 35 countries in the region.• Turned around QA functions in 2008 with modern quality tools, effective planning & analysis and improved coordination.• Promoted a total quality philosophy with modern QA technology & tools and played a pivotal role in commissioning, start-up, validation and regulatory approval for new manufacturing facility for pharmaceutical liquids.• Led the project of first Cosmetic GMP certification in Pakistan from UAE to achieve multimillion Dollar export business and optimized product technology platform through R&D assignment on a cosmetic product for launches in 5 countries.• Provided technical support through audit, visits, layout up-gradation and documentation for GMP and Microbiology compliance at manufacturing sites in South Africa and UAE.• Led the regional Microbiology role in Africa Middle East to enhance facility and product compliance through audits, visits and follow-ups.Key Responsibilities:• Managing and developing the QA/QC function and promoting a total quality philosophy at all levels.• Spearheading a team of 20 highly qualified Pharmacist, Chemist and Microbiologists for GMP compliance and continual improvement.• Managing Validation/qualification activities as per Validation Master Plan (VMP)• Managing Internal and external GMP, regulatory and global QA audits to ensure sustained productivity as per corporate GMP standard.• Managing Complaint, Deviation, CAPA & Change Control.• Technical support to engineering function for plant expansion and new facility design• Looking after regional Microbiology (Africa M. East) for compliance and continual improvement in manufacturing plants.• Managing ISO 9001, 22716 and 17025 certification for pharma and cosmetic plants.

Inducted as Asst. Manager Validation & Documentation and crafted an upward growth curve to merit promotion to the position of Manager Validation in 2004 and Manager GMP & Technical Services in 2006.Highlights:• Provided first-line support during construction, day to day operations, civil and HVAC qualification, Lab Setup, successful MOH inspection & approval and start-up of manufacturing operations in a new state-of-the-art pharma plant. • Developed new methods of working to further grow the effectiveness and improve site performance through Validation, Calibration, CAPA, FAT, auditing and Change Management.• Assured procedure in place and drafted plant wide SOP system, Site Master File and Validation Master Plan as per PIC/s and international guideline. • Improved manufacturing reliability by attaining company wide ISO certifications (ISO 9001& 14001) in the capacity of Management Representative. • Coordinated production manufacturing processes and carried out aseptic area qualification, Media Fill, Sterilizers Validation, Equipment Qualification, and Process Validation as per international guidelines.Key Responsibilities;• Ensured the integrity of the quality system is maintained and developed thereby contributing to the achievement of consistent operational performance and standards. • Performed and assisted with validation of manufacturing processes and tools, maintained documentation for manufacturing, including work instructions.• Ascertained that staff is adequately trained to ensure compliance with GMP requirements and quality standards through both internal/external audits.• Was responsible for ensuring that all working areas and surrounding areas are compliant to GMP, well kept and maintained with strict adherence to working to current pharmaceutical industry standard of GMP and EH&S, and strict timelines.

Highlights:In this short period of time, I established proper validation system, designed validation policy and protocol of various equipment and process in the light of FDA. Execute and document process validation of newly launched I.V. product and OSD manufacturing equipment. Established Audio/Visual based GMP training of floor personnel. Designed proper SOP system for plant operations. Established Statistical Process Control concept within the plant. Arranged vigorous training of management staff on validation concepts and Statistical Process Control tools.

Joined as a Microbiologist and merited promotion to the position of Sr. Microbiologist through exceptional performance.Highlights:• Played a pivotal role in developing new product through Lab scale manufacturing of new I.V. product (3 lots).• Enhanced quality and reliability of Microbiology analysis and Validation as per guidelines of corporate guidelines. Key Responsibilities:• Handled day to day operation of the in-house microbiological testing services to the Manufacturing departments and plant operations.• Developed, optimized and validated new test methods, including protocol and report writing, analyzed and reported of test results.• Carried out a comprehensive range of microbiological testing, including sterility testing, Endotoxin testing, Environmental monitoring as well as microbiological challenge testing.• Effectively troubleshoot problems and interacted comfortably with other departments and clients. Conducted routine analysis of samples and the support functions to ensure that work is performed in an organized and timely manner.

Mba

Certification / Diploma, Manufacturing And Quality Assurance

Msc, Microbiology

Bsc (Hons.), Microbiology, General