WASEEM AZIZ

Mississauga, Ont. L*V *A*

647-***-**** acgkpb@r.postjobfree.com

PROFILE

A Pharmaceutical Professional with extensive and hands–on experience in leading and overseeing pharmaceutical

production (sterile & non-sterile), preventative maintenance and project management in Multi-National global companies.

Spearheaded all aspects of pharmaceutical manufacturing, packaging operations and quality management. Proven track

record of innovative, talented and result driven leadership focusing on achieving exceptional results in the highly

competitive life sciences environment that demands continuous improvements. Completed projects within critical

deadlines and maintained exceptional performance in high-pressure situations.

Areas of Expertise:

• Production Management & Equipment Maintenance, Facility Operations and Design, Project

Management

• Sterile and Non Sterile Product Manufacturing and Packaging, Planning and Scheduling

• Quality Assurance, Audits (FDA/Health Canada/ISO) and Process Improvement

• Certified JHSC Member. RSO for sealed source user

PROFESSIONAL EXPERIENCE

Cibavision(A Novartis Company), Mississauga 2003 – Present

Project Manager, Technical Projects (2008-Present)

Provided Leadership to production for successfully implementation of change in cultural paradigm; accountable for

projects worth up to $500,000 in the regional sterile operations plant of over 300 people of a Multi-National global company.

• Revamped internal procedures and controls, reorganized/reallocated team members and implemented best

practices and monitoring systems in support of continuous improvement.

• Managed Production Resources; in projects related to facility upgrade; Continuous Quality Improvement and

Health & Safety by ensuring conformance to cGMPs, SOPs and company policies.

• Identified and implemented systems for production associates to attain higher standards of safety, quality and

productivity which are aligned with company goals and objectives. Identified concerns, possible risks, quality and

compliance issues with projects.

• Participated in FDA / Health Canada audits. Ensured Engineering Department “Audit Ready” status by managing

the review and update of critical system and facility drawings, moving them to a controlled documentation system.

• Monitored Engineering department compliance and conducted investigation of non-conformances and

implementation of CAPAs. Consistently closed NCR’s/CAPA’s within the required timeframes.

Key Accomplishments

• Ensured flawless execution of project activities, consistently meeting timelines for semi-annual shutdowns.

Completed the 2013 summer shutdown ahead of schedule despite the addition of six projects late in the planning

process. Reduced clean room downtime due to room certification process from 4 days to less than 2 days.

• Created and implemented plant shutdown through CMM (MP2) which resulted in increasing efficiencies,

accelerated customer satisfaction and slashed downtime. Scheduled and successfully coordinated several overlapping

Engineering projects for a major upgrade in 2012, with a combined capital budget of $5 M.

• Planned and managed semiannual media fills, clean room restorations and clean room certifications, validation

studies, calibration as per regulatory requirements and Novartis Quality Manual. Media fill cycle time reduced from

24 days to 22 days; clean room restoration process improved from 3days to 2 days.

• Managed remediation of the Global Quality Manual gaps assigned to Engineering, resulting in full and timely

completion.

WASEEM AZIZ 2

• Designed, installed and qualified two raw material heating chambers; project completed on time and within

budget. Self-performed activities resulted in saving of additional $5000.

Production Manager (2003-2007)

Reported to Director, Production and was responsible for leading a team of 30 key Operations and Maintenance staff and a budget of $

500,000. Managed overall operation of high speed aseptic filling lines for Optic Lens Care products. Facility produces 70Million units

annually.

• Managed high speed lens care solution aseptic filling and packaging lines. Maintained compliance by

ensuring conformance to cGMPs and SOPs, company policies and health and safety requirements. Scheduled

resources (equipment and personnel) to meet production targets.

• Provided team leadership and supervision including motivation, coaching, training, development, recruiting

and appraising.

• Managed short and long term budget which included: strategic and tactical planning human resources,

facilities and equipment upgrades for filling department.

Key Accomplishments

• Designed and ensured the final quality standard of a major facilities renovation project by providing deviation

and deficiency analysis for the team. This resulted in reduction of EERs substantially in the clean rooms.

• Contributed successfully in selection and implementation of online vision systems $80,000 project and

palletizers $125,000 project to reduce labor head count per line by 20%

• Improved quality projects i.e. on line leak detection system $ 50,000 project, selection and installation of

Autoclave $ 200,000 project and clean room upgrades + $200,000 project.

• Farming out and successfully implemented sterile gown as part of CQI. Resulted in reduction of one head

count and EERs as well.

AstraZeneca Inc., Mississauga 1998 –

2003

Production Supervisor

Supervised team of 16 key Operations and Maintenance staff in compounding, sterile filling (Small Volume Parenteral and

Dental Cartridges) and maintenance

• Eliminated unscheduled downtime by developing a master scheduler which ensured the proper flow of raw

materials and timely communication with supporting department.

• Planned, organized, monitored and evaluated activities within health and safety, corporate and Health Canada

regulations.

• Actively participated in continuous quality improvement projects.

• Coordinated and planned activities related to validation and QA audits. Key player in reducing and closing

non conformances report.

• Provided leadership in the training and development of all production personnel.

• Implemented staggered shifts resulted in saving of $40,000 per year.

• Led project of developing and improving electronic batch record on SAP system to reduce rework.

• Developed sanitation program for machinery resulted in significant reduction of microbiological counts

Prior Experience

AZ Pharmaceutical Co. Ltd. Production Manager

PDH (Pvt.) Ltd. Sr. Production Pharmacist

Popular Chemical Works (Pvt.) Ltd. Production Pharmacist

Aventis Pharma Ltd. Production Pharmacist

EDUCATION & PROFESSIONAL DEVELOPMENT

WASEEM AZIZ 2

Bachelor of Science equivalence from University of Toronto for Bachelor of Pharmacy; Gomal University.

Associate’s Certificate in Project Management; The George Washington University, Washington DC

Industrial Drug Legislation, Management Information System, Labor relations, Health Safety and Environment,

Finance for Non-Financial managers, Clean room Validation and Aseptic Filling, Leadership development and Project

Management.

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