Customer Service Manager
Resume:
QUALITY CONTROL AND QUALITY ASSURANCE PROFESSIONAL
A proactive and organized Quality Control and Quality Assurance professional with over 24 years of experience in the pharmaceutical industry. An effective problem solver and results driven individual known to motivate and empower others. An excellent communicator with focus and determination in building outstanding teams. Known for scientific approach to investigations. Capacity to cope with high stress levels and aggressive time lines. A flexible and compassionate leader, able to balance business and team needs to meet goals and objectives. ACHIEVEMENTS
Prepared annual budgets of $1.5M and maintained expenses and capital expenditure at or below approved budgets from 2001 – 2010.
Saved $300K in operational budget by lab relocation and improved testing synergy with other labs.
Led the Validation Laboratory in completing all testing of over 30 products as per revalidation plan as part of the re-start commitment made to Health Canada. This contributed in completing all re-validations within submitted timelines.
Successfully managed departmental Health and Safety ensuring in zero time loss due to injuries. Ensured the department is in constant state of Current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) compliance with no major observations during internal audit, Health Canada audit and FDA audit.
Promoted and led continuous improvement in order to maintain a high degree of compliance while optimizing the operating cost.
Created well-respected teams with highly motivated and dedicated members by active management resulting in a positive team environment.
Cross-trained the team to ensure the flexibility of skills and efficient output. CAREER HISTORY
QCL QUALITY COMPLIANCE LABORATORIES Jun. 2014 – Aug. 2014 A contract testing laboratory
LABORATORY SUPERVISOR
Led a team of 9 responsible for testing and troubleshooting analytical issues to ensure that high quality results were available to clients.
Managed and oversaw product testing activities of laboratory personnel to ensure timely completion of projects.
Scheduled training for staff in test methods, analytical equipment and laboratory technique ensuring high quality and efficient output.
Conducted out of specification investigations and troubleshooting and suggested improvements to test procedures if necessary.
Reviewed and approved change controls and test procedures.
Consistently met aggressive timelines, priority changes and heavy workloads to meet business requirements.
SARYU PATEL BSc
28 Feather Reed Way
Brampton, ON L6R 3A3
***********@*****.***
SARYU PATEL 2
APOTEX INC. 2011 – Feb. 2014
The largest Canadian owned pharmaceutical company
SUPERVISOR, QA CLEANING VALIDATION (2012 – 2014)
Led a team of 3 responsible for executing validation and monitoring of cleaning processes and In-Process Bulk release.
Oversaw the daily operation for a team of 3 to ensure timely and efficient completion of cleaning validation/cleaning verification/In-Process Bulk testing and release activities. This resulted in timely releases of production equipment, validation of cleaning processes and timely releases of In-Process Bulk products.
Managed and planned the activities related to In-Process Bulk testing and Master Formula review for timely releases of In-Process Bulk products. Coordinated these activities with Quality Assurance In Process (QAIP) team to ensure release of bulk on time.
Identified non-conformances to the manufacturing management, provided support and guidance for investigations. Worked with other departments to determine root cause and corrective and preventive action (CAPA) and implement change.
Reviewed and approved investigations in a timely manner in order to release production equipment and In-Process Bulk on time. Identified, reviewed and approved CAPA on time.
Developed new and revised existing SOP’s to ensure constant compliance with regulatory guidelines.
Provided support to the Early and Safe Return to Work program.
Managed and planned staff cross-training for QA In-Process activities such as Bulk release and cross-training of QA-In Process staff for Cleaning Validation activities to ensure high quality and efficient output.
Utilized LabWare LIMS, SAP, Trackwise, Microsoft Word, Excel and PowerPoint to manage activities for Cleaning Validation, Bulk releases and investigations effectively.
Supported QA and the Manager during inspections by regulatory agencies.
Recruited, managed, trained and developed the team through performance reviews and development plans.
Consistently met aggressive timelines, priority changes and heavy workloads to meet regulatory/business requirements.
SUPERVISOR, QA CLEANING VALIDATION (2011 – 2012)
Led a team of 8 responsible for validating cleaning processes.
Oversaw the daily operation for a staff of 8 to ensure timely and efficient completion of cleaning validation and cleaning verification activities. This resulted in a timely release of production equipment and validation of cleaning processes.
Reviewed and approved cleaning validation risk assessments/protocols, IQ/OQ/PQ protocols and summary reports.
Reviewed and assessed impact of changes to the validation status, using the appropriate change control procedures.
Ensured staff training is current by providing them with training gaps on a regular basis. Cross-trained staff within the department to ensure the flexibility of skills and efficient output. SARYU PATEL 3
MYLAN PHARMACEUTICALS ULC (Formerly Genpharm ULC) 1988 – March 2010 A leading, diversified generic and speciality pharmaceutical company. MANAGER, QC-VALIDATION LABORATORY (2002 - 2010)
Led a team of 12, including analysts, lab support and data reviewer in process validation, cleaning validation testing and troubleshooting analytical issues to ensure that quality products were available as required in the domestic and international markets.
Managed and planned the activities related to process validation/engineering, cleaning validation and release testing in support of new product launches and ongoing operation. Throughout this period, key molecules were launched at the time of regulatory approval.
Managed lab output, by developing a method and protocol review system, proactively communicating with manufacturing and technical operations prior to new product launches and release testing.
Managed, trained, and developed team through performance appraisals and development plans.
Unified processes across validation and QC laboratories by discussing and aligning testing methodologies and troubleshooting methods with other internal teams.
Supported Analytical Method Transfer to USA, India, Australia and the EU by coordinating and managing testing, troubleshooting and site questions to complete testing within submission deadline.
Performed out of specification (OOS) investigations and troubleshooting utilizing strong knowledge of analytical instruments and implemented improvements to test procedures resulting in increased productivity.
Revised, reviewed and approved SOP’s, test procedures and specifications. Reviewed and approved cleaning validation/process validation protocols.
Managed departmental Health and Safety by conducting monthly health and safety inspections and communicating findings to JHSC.
Actively participated during inspections by regulatory agencies (Health Canada, FDA etc.) as well as client and internal audits.
Cross-trained staff within the lab and in other departments ensuring high quality and efficient output.
Consistently met aggressive timelines, priority changes and heavy workloads to meet market demands.
GROUP LEADER, VALIDATION LABORATORY (2000 - 2002)
Led a team of 10, including analysts, lab support and data reviewer.
Contributed to the launch of new molecules by planning and executing all activities in testing process validation, process qualification and cleaning validation samples in support of new product launches, Regulatory submissions and ongoing operations.
Conducted performance appraisals and performed back-up duties of budget responsibilities for Director of Quality.
SARYU PATEL 4
SENIOR R & D ANALYST (1994 - 2000)
Planned activities for staff to ensure timely and efficient completion of stability testing and data reviewing in order to meet submission timelines.
Performed pre-formulation trial, raw material, and finished product testing. Trained junior analysts. Developed dissolution methods and tested compendia methods resulting in meeting regulatory submissions timelines.
Coordinated and supervised testing during Group Leader’s absence. Performed investigations, troubleshooting and implemented improvements for increased productivity.
LAB ANALYST (1988 - 1994)
Analyzed pharmaceutical raw materials, in-process samples and finished products. Performed troubleshooting and investigations when required, resulting in successful launches of major molecules.
EDUCATION AND PROFESSIONAL DEVELOPMENT
Bachelor of Science (Chemistry) – University of Mumbai, India DDI Leadership Development, 2013
The Annual Product Review, PSG, 2010
Process Validation Best Practices, AAPS, 2007
Critical Cleaning Processes and Cleaning Validation, AAPS, 2007
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