Faiza Ismail
Glen Ellyn,IL
Summary
Pharmacist with extensive experience in formulation and process development of drugs and devices in different departments like production, quality,validation and warehouse, as well analytical expertise bringing projects from prototype to pilot scale up through commercial launch, including tech transfer activities.Excellent team member, flexible in rapidly changing environment. Working Knowledge of, cGLP, cGMP, SHE and FDA Regulatory guideline such as 21 CFR 820,ISO 13485 , ISO 9001 and OSHA . Have hands on experience and knowledge of technical writing GMP documents like SOPs,MBRs, Deviation writing and working with QMS software like Trackwise, SAP and Documentum (CDMS).
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Project Coordinator Quality Assurance
AbbVie
01.2023 - Current
- Kept projects on schedule by managing deadlines and adjusting workflows.
- Supervised multiple projects from project start through delivery by prioritizing needs and delegating assignments.
- Liaised between departments to facilitate communication and keep appropriate parties updated on project developments.
- Managed competing demands and professionally adapted to frequent change, delays and unexpected events.
- Maintained database and spreadsheets with accurate inventory and status.
- Monitored project progress, identified risks and took corrective action as needed.
- Performed integration activities between Allergan and AbbVie QRM related documents including FMEAs and SRA's.
- Created SRA template for 115 Drugs/Devices and Combination product to integrate multiple Risk documents in to one system risk assessment.
- Gathered and Comprehend data from different software's like Attache, OneV and Linkus to harmonize list of products from Allergan and Abbvie.
- Facilitated workshops to collect project requirements and user feedback.
- Wrote technical narratives to document processes and design changes.
Sr.Technology Transfer Scientist and Process
Fresenius Kabi USA
11.2019 - 10.2022
- Projects and Achievements: - Successfully validated CIP/SIP machine for cleaning of Tanks in compounding for efficient cleaning and sanitizing by reducing over all cleaning time and head counts required to perform the task
- Planned and executed project "Raising Canes", Identified the opportunity during a continues improvement cycle to increase the productivity of most running products by filling the product on an alternate line
- Prepared and performed all PPQ related documents and activities, Hence resulted in increase productivity of Cane family that helped meeting the production and planning goals
- Participated in different expansion projects by performing Risk assessments and FMEA of products
- Day to Day Activities:
- Support the project team with respect to scaling up processes , new equipment and procedures, equipment and process validation, and manufacturing of development, stability and process qualification batches
- Co-ordinate the preparation of the manufacturing site for the manufacture of new products
- Prepare master batch records and protocols for the manufacture of development, stability and process performance qualification batches
- Technically assess the manufacturing process by risk assessments and FMEA to design robust manufacturing processes
- Perform Cleaning risk assessments by calculating ADE limits of drug products
- Optimizes product and process to reduce costs or improve value to support value engineering initiatives
- Provide information and documentation needed for regulatory submission or responses as required
- Support cleaning validation/verification program by calculating cleaning limits, acting as study director, swab sampling and evaluating product for cross contamination
- Use of Product lifecycle management tools and techniques to improve process robustness
- Provide technical support to the Product Stream, to resolve technical problems
- Undertake self-audits on a regular basis, to ensure implementation of the required technical and GMP standards for devices like 21 CFR 820 and ISO 13485 and 9001
- Apply scientific knowledge to projects
- Analyze complex data critically by applying advanced computer skills
- Responsible to develop robust, efficient process and sets the control strategy for assigned NPIs projects
- Lead the scale up from lab to Pilot and finally technical transfer from the pilot plant to the factory while working and in conjunction with Supply chain and other stake holders
- Independently design experiments and carries out scientific work, write and/or review/authorize GMP-critical documentation, such as experimental reports, Batch Records, development and technology transfer reports PPQs, investigation and research plans to fit overall project objectives
- Perform Risk assessment with key cross functional stakeholders and subject matter experts to set up the control strategy
Sr. MQA Release Specialist
Fresenius Kabi USA
08.2019 - 11.2019
- Review of batch record, R-Lots, Contract manufacturing lots and associated testing results and empower reports
- Support in disposition of finished batch record
- Review stability batches
- Parking batches on SAP and generating COAs.
Production Executive
Reckitt Benckiser Pakistan
12.2018 - 05.2019
- Key Roles and Responsibilitie
- Looking after batch vise manufacturing and packaging of oral NSAID
- Developing and proving processes for OTC products
- Understanding of the Consumer Health / FMCG (Fast Moving Consumer Goods) and the product development process involve in it
- Planning and scheduling Day to day production of batches as per DPR
- Lead a team of Non-management staff/Operators
- Participate in Global Audits of Quality and EHS
- Timely completion of batch documents and update the transactions on JDE
- Daily OEE monitoring and reporting via OEE calculator.
Operations Officer
GlaxoSmithKline Pakistan Production
08.2016 - 12.2018
- Key Roles and Responsibilities
- Coordinate day to day line activities of associates performing packaging and material handling operations to ensure manufacturing objectives are met
- Assign resources to ensure appropriate coverage of line specific tasks
- Identified control gaps in processes, procedures and systems through in-depth research and assessment and suggested methods for improvement
- Produced and reviewed audit reports for submission to inspector general and advised inspector general on audit recommendations and internal controls
- Drove continuous improvement initiatives within environmental health, safety and sanitation areas
- Championed new Lean strategies, framework and project elements to drive multidisciplinary growth and process overhaul
- Managed development and implementation of lean and continuous improvement manufacturing initiatives across production environment
- Work with production staff
- Use hands-on approach to communicate daily and involve production staff in problem solving
- Develop a high-performance work team with high levels of worker morale, satisfaction, and performance
- Help production staff succeed through performance management
- Provide coaching and performance communication to support development
- Review general status of production schedules to identify and resolve problems
- Ensure the desired product quality levels are achieved through use of standard work and training to those standards, training in operation and inspection techniques, and use of tools/data
- Support and implement new, customer-focused processes in accordance with lean principles and practices
- Provide training and coaching to improve standard work, work center organization (5S), and housekeeping
- Actively provide change leadership as required
- Support and foster an environment of continuous improvement by encouraging production staff to challenge existing processes and implement solutions that enhance the overall effectiveness of the operation
- Support production staff in understanding company policies and practices
- Maintain time and production records
- Take notice of process related problems and support production staff in taking corrective action to improve the overall performance of the team
- Communicate with and listen to production staff on a daily basis regarding work team performance, strategic initiatives, policy changes, safety, quality, etc
- Communicate with other supervisors and appropriate personnel regarding equipment, safety, work center schedules, company policies and practices, performance improvement plans, etc
- Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback
- Maintains a safe and professional work environment
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- Technology Transfer Scientist at GSK Korangi site
- (Product Development)
- Key Roles and Responsibilities
- Checking and updating labels information as per requirement
- Participated in project to include clinical data on labels
- Verification of the contents of labels with regulatory authorities
- Getting approval of previous or newly edited labels from regulatory and government bodies
- Technical support to Source change initiatives – MRAs
- Technical support to Site project activities – TRAs
- Ensures all work is conducted in accordance with written procedures (e.g
- Quality and safety), methods & batch documents, etc
- Identifies, challenges, develops and implements written procedures (e.g
- Quality and safety) methods & batch documents, etc
- Use of Product lifecycle management tools and techniques to improve process robustness
- Provide technical support to the Product Stream, to resolve technical problems
- Product and technology transfer using product lifecycle management approach (Including MRA/TRA)
- Undertake self-audits on a regular basis, to ensure implementation of the required technical and GMP standards
- Assist in productivity improvement projects where required and provide relevant technical input
- Support the implementation of Technical Risk Assessment and product performance assessment
- Technical issues like product transfers and new product development among and between various sites
- To deploy GPS in office that include 5s and zoning
- Prepares and executes equipment life cycle activities for equipment and systems within the GMP pilot plant
- Provides technical leadership and support to project teams during manufacture of product within the pilot plant
- Identified and drive technical/process improvement opportunities within the pilot plant
- Develops and executes cleaning validation activities within the pilot plant
- Provides technical support and troubleshooting assistance for all equipment and systems within pilot plant
- Interfaces with external vendors and service providers to arrange equipment demonstrations, troubleshooting, and repairs
- Produces or contributes to, departmental quality documentation (including SOP’s, batch documentation, validation protocols & reports)
- Supports specific safety and quality responsibilities for department and site (e.g
- GMP, Audits, Health & Safety)
- Delivers all EHS standards and expectations on site and within the pilot plant, including development of suitable risk assessments for pilot plant equipment and activities.
Education
PGD Pharmaceutical Engineering - Pharmaceutical Industry
NED University
Karachi 01.2024
Doctor of Pharmacy - Pharmacy
University of Karachi
Pakistan01.2015
Skills
- Lean manufacturing
- Process development
- New product introductions
- Waste management
- Production planning
- Maintenance scheduling
- Microsoft Word Suite
- Employee timesheet processing
- Report development
- Documentation and control
- Recordkeeping
- Regulatory compliance
- Agile Projects
- Risk Management
- Six Sigma Methodologies
- Technical Writing
- Product Development
- OSHA Regulations
- Design Development
- Workflow planning
- Writing reports
- Team management
- MS OFFICE
- Track Wise
- JD Edward
- CDMS
- CGMP
- OneV
- linkus
- Attache
Certification
- Lean Sigma Green Belt in health care 51354866 - Management and Strategy Institute
- Project Management Qualified 94470956 - Management and Strategy Institute
Languages
English
Full Professional
Hindi
Full Professional
Gujarati
Native or Bilingual
Urdu
Native or Bilingual
Timeline
Project Coordinator Quality Assurance
AbbVie
01.2023 - Current
Sr.Technology Transfer Scientist and Process
Fresenius Kabi USA
11.2019 - 10.2022
Sr. MQA Release Specialist
Fresenius Kabi USA
08.2019 - 11.2019
Production Executive
Reckitt Benckiser Pakistan
12.2018 - 05.2019
Operations Officer
GlaxoSmithKline Pakistan Production
08.2016 - 12.2018
PGD Pharmaceutical Engineering - Pharmaceutical Industry
NED University
Doctor of Pharmacy - Pharmacy
University of Karachi
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