Quality Assurance Manager

BALBIR DULAY • ***-* Plymouth Road • Valparaiso • IN • 46385 • 269-***-**** •

***********@*****.***

Professional Profile

Self-motivated and successful quality assurance manager with 27 years of QA/QC experience,

who understands both manufacturing and analytical chemistry to assess product’s quality for

regulatory compliance and business. Team leader in making quality decisions related to problems

in analytical procedures, manufacturing processes, validations, API sources, technicians,

instruments, SOP’s, validation reports and specifications. Quality Engineer in reviewing statistical

analysis for defects, recalls and process capabilities. Promotes superior quality by investigating

out-of-specification results, trending release data for annual product reviews, reviewing batch

records for customer complaints, writing non-conforming material reports for operations. Proven

cross-functional project manager committed to support new product development, technology

transfer and commercial products in the market. Coaching six sigma for continuous improvement

in all the processes to all the employees. Subject matter expert in FDA documentation required

for solid dosage and sterile injectable filing. Objective of my career is to support the business by

releasing quality products in the market.

Approval of Cleaning Validation Protocols and Stability Protocols • Approving out of

specification results • Internal and External Auditing for Contract Manufacturing •

Employee Training and Development Program • Instrument Calibration Program •

Documentation Building • AQL Sampling • Budget Development • Approving Batch

Records, Change Controls, CAPA and Deviations • Analytical Method Development and

Validations • Clinical Study Coordination

Equipment/System Expertise

Validation of 4 packaging lines: Bottle Quality Assurance of Chemical Measurements

Filler heads, Sealers, Counters, Labellers in Raw material analysis, in-process testing,

finished product and stability samples.

Analytical Method Validation: Ibuprofen, Event Management in manufacturing for

Docusate Sodium, Poloxamer 28, USP Nonconforming material reports, Deviations, or

methods reliability Corrective Actions or Preventive Actions

Mixer and Compression Machine Transfer of analytical methods and quality

Validation: Korsch XL 400 systems between different facilities

Validation of Environmental Monitoring Compiling Annual Product Reviews for all NDA

for Stability Chambers, Manufacturing approved commercial products. Managed post

Facility and Warehouse. approval changes as per FDA guidelines

HPLC Validation and calibration including Managed Contract Manufacturing of Sterile

Millennium Software liquids and Softgel capsules

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BALBIR DULAY • 440-1 Plymouth Road • Valparaiso • IN • 46385 • 269-***-**** •

***********@*****.***

PROFESSIONAL EXPERIENCE

MonoSolRX, Portage, Indiana • 2012-2013

Strip manufacturer of Suboxone

QUALITY ASSURANCE MANAGER

• Managed four floor QA Supervisors for the manufacturing process 24x7. Was responsible

for overseeing floor operations and was the point contact for any process problems or

quality issue round the clock. Communicated using a Blackberry device through email,

text and phone.

• Coordinated five QA Associates for maintenance of quality systems: change control,

CAPA, raw material release, training and deviations.

• Released the batches approving deviations and non-conformances reports. Upgraded the

batch record review process and release process according to corrective action.

• Prepared Annual product reviews for the products.

LLOYD INC. OF IOWA, Shenandoah, Iowa • 2008-2012

Private manufacturer of Human Thyroid drug, sterile injectable and nutritional supplements

QUALITY ASSURANCE MANAGER

Private manufacturer of Human Thyroid drug, sterile injectable and nutritional supplements (Solid

Dosage and Sterile Controlled liquids)

• Hosted three FDA inspections, wrote corrective actions for first two inspections and there

was no 483 issued to the site for the third inspection.

• Started quality investigation program and keeping it current by writing customer

complaints, investigations and corrective actions.

• Approved operation’s planned and unplanned deviations, validation protocols, SOP’s,

specifications, stability protocols and change controls on daily basis.

• Maintained anniversary dates for annual product reviews for all approved products.

• Decided AQL inspection criteria for packaging defects for all different packaging lines.

• Provided quarterly training to all employees to update cGMP guidelines.

• Oversee product releases and manufacturing 24 X 5 with three quality auditors, two

documentation co-coordinators and four QA floor inspectors.

• Acted as a quality Liaison between Akorn Inc. and Lloyd for controlled Sterile products.

Audited Akorn annually and approved all change controls and investigations for the

manufacturing. Released sterile products for packaging at Lloyd.

• Managed Supplier qualification program for raw materials.

PERRIGO COMPANY, Allegan, Michigan • 2004-2007

A $1B+ manufacturer of solid, liquid and gels over the counter and prescription products.

Quality Stability Subject Matter Expert

A $1B+ manufacturer of solid, liquid and gels over the counter and prescription products.

• Evaluated out-of-specification stability results which resulted either in recalls or analytical

method improvements.

• Collaborated with R&D analytical team leaders for method improvements and transferred

to quality technicians.

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BALBIR DULAY • 440-1 Plymouth Road • Valparaiso • IN • 46385 • 269-***-**** •

***********@*****.***

• Approved 400 change controls/month in Track wise to support 8 packaging Engineers

for implementation of change control on packaging lines .

• Approved analytical specification and analytical methods in Track wise for 20 R&D

chemists.

• Approved R&D accelerated studies to assign expiry dates in SAP for manufacturing to

support post approval changes.

• Decided on external quality for Soft gels by reviewing stability data, batch records and

protocols from contract manufacturer.

• Controlled stability data in SLIM STAT for 1800 stability studies. Used SLIM STAT to pull

samples, assign expiry and turnaround of stability samples.

• Spearheaded transition of marketed products stability program from R&D to QC

department to ensure FDA compliance.

• Verified expiry of 300 commercial products using stability data and statistical analysis.

Handled difficult task of informing the Senior Management if the data was not supporting

the expiry.

• Monitored Stability Chambers for environmental conditions 24X7 with maintenance.

SYNTHETECH, INC., Albany, Oregon • 2001-2003

A $10M manufacturer of active pharmaceutical ingredients for an international market. (API

Manufacturer)

Quality Control Manager

• Managed 7-person in QC and R&D lab to release of 25 products monthly by evaluating

lab data, comparing with previous batches and investigated out-of-specification results.

• Drove lab renovation project, enhanced documentation, and upgraded lab equipment and

technicians to cGMP/QC standards.

• Launched instrument calibration program and IQ/OQ/PQ for all instruments.

• Provided analytical support 24X7 to operation in manufacturing processes

• Acted as a method transfer liaison between R&D chemist and QC.

• Answered vendor’s analytical issues for API and assisted them in method transfer.

• Assisted company with 35 customer audits in 3 years by upgrading analytical laboratory to

cGMP standards.

JAMIESON LABORATORIES, Windsor, Ontario • 1999-2000

A leading manufacturer of vitamins and natural healthcare products in Canada.

Quality Control Supervisor

• Oversaw monthly releases of 400 raw materials, 250 in-process materials, and 300

finished products.

• Managed 18-technician for daily schedules and backup training. Organized the lab for

better turnaround for supporting operation activities.

.

ACCUCAPS INDUSTRIES, Windsor, Ontario • 1997-1999

A contract manufacturer of OTC and Prescription Soft gel capsules in Canada

R&D Chemist

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BALBIR DULAY • 440-1 Plymouth Road • Valparaiso • IN • 46385 • 269-***-**** •

***********@*****.***

• Build a R&D lab inside a R&D formulation lab for analytical support for all the

formulations.

• Validated analytical methods for Ibuprofen and Docusate Sodium.

• Utilized HPLC and wet chemistry methods to undertake cleaning validation and analyzed

reactor swab samples.

• Led effort to transfer Isotretnoin analysis method from Abbott to Accucaps by creating

method transfer SOP, analyzing raw material, and conducting in-process and finished-

product testing.

• Drove expansion of prescription product business by implementing quality control

procedures, aligning GC and USP procedures, and collaborating with Waters to enhance

Empower reports.

• Calibrated R&D instruments utilizing instrument calibration procedure and IQ/OQ/PQ from

QC lab.

• Played instrumental role in transferring technology from Abbott as pharmaceutical client

and served as Accucaps/Abbott quality liaison for contract manufacturing.

MDV TECHNOLOGY, Dearborn, Michigan • 1994-1996

A manufacturer of controlled gel for surgeons and developer of an innovative drug

delivery system

Quality Assurance Scientist

• Ensured manufacturing and packaging quality by conducting cGMP inspections under

consultants, reviewing manufacturing and packaging batch record. Supervised sterile

vial packaging activities and stability activities to ensure quality of gel for the patients.

• Monitored QA instrument calibration program for the lab and manufacturing facility.

• Supported clinical trial in Europe by checking CRO activities and their documentation

with European standards.

• Trended clinical data for all patients and made charts for IDE filing with FDA.

Coordinated stability program for testing and prepared stability reports for filing.

• Facilitated IDE filing by leveraging analytical chemistry experience to check excipients

certificate of analysis, API quality, residual solvent validation reports, Specifications

and stability studies.

• Acted as a QA team leader for CRO clinical studies, providing product and packaging

component quality.

CLAYTON ENVIRONMENTAL CONSULTANTS, Windsor, Ontario • 1985-1993

An international, $1M provider of environmental testing analytical Service

Chemist, Group Leader, and Quality Assurance Manager

• Utilized GC, HPLC, AA, and wet chemistry to analyze samples as a Chemist. Led and

expanded group by hiring chemists and training them in methods, compliance, and

corporate quality expectations using quality manuals.

• Upgraded lab quality by creating six sigma quality control charts and range charts for 350

analytical methods.

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BALBIR DULAY • 440-1 Plymouth Road • Valparaiso • IN • 46385 • 269-***-**** •

***********@*****.***

• As a QA Manager, controlled the precision of the analysis using control charts. Reviewed

200 customer reports for quality and regulatory compliance each month. Answered all

customer quality complaints and turnaround issues.

• Expanded Canadian business 100% by securing 200 new clients providing good

turnaround time.

• Generated 75% of company’s revenue by handling major cleaning environmental project.

• Responsible for maintaining accreditation of Analytical Quality Assurance program for 8

years from American Industrial Hygiene Association for analyzing low level industrial

Hygiene samples and loaded environmental samples from Ministry of Environment

Canada.

• Upgraded documentation in lab note books and electronically for better quality.

PRESENTATIONS/PUBLICATIONS:

• Presented quarterly cGMP training to all employees in the company for three years.

Covered 10 cGMP modules from Skills plus.

EDUCATION

• 1984 Masters of Science (Chemistry), University of Windsor, Windsor, Ontario, Canada

• 1985 Bachelor of Education, University of Windsor, Windsor, Ontario, Canada

TRAINING

• GMP Essentials and Trainer Certification Skills Plus International

• cGMP training McCarthy Consultant Services Inc.

• Chemistry of Resolution- Waters

• Annual Product Review and Stability Reports The University of Wisconsin

• Complying with FDA/ICH Requirements for Stability Testing PTI International

• Method Development Waters

• Electronic Laboratory Notebook Barnett International

• Dissolution Vankel Technology Group

• Train the Trainer Skills Plus

• English Communication Western Iowa State

• Developing and implementing effective Stability Program The University of Wisconsin

• Minitab Training for statistical Analysis Minitab Institute

CERTIFICATIONS

• 1997 QS-9000 Auditor/Lead Auditor through STAT-A-MATRIX

• 1992 Certified Chemist by Association of the Chemical Profession of Ontario, Canada

• 1985 Certified Teacher by University of Windsor, Windsor, Canada

PROFESSIONAL ASSOCIATIONS

• American Society for Quality (ASQ)

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BALBIR DULAY • 440-1 Plymouth Road • Valparaiso • IN • 46385 • 269-***-**** •

***********@*****.***

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