Quality/Project Manager

Nisha Singh, Ph.D.

***, ******* ***** **** *******, NJ-08520

Home phone: 609-***-**** e-mail: s7yjth@r.postjobfree.com

SUMMARY: Nine years of extensive experience in analytical and R&D lab for all the activities, trained many analysts. Led the group for many years and set the lab for GMP environment. Proven ability to take initiative and meet deadlines with timeliness, accuracy and a high caliber of work, as well as excellent communication skills. Preparation and review of standard operating procedures (SOP), standard test procedures, deviation reports, troubleshoot method and instrumentation problems. Knowledge of Industry guidance and regulatory issues. Experience in HPLC, Dissolution, GC, Spectroscopy etc.

EXPERIENCE: PHARMACEUTICAL INDUSTRIES IN NJ

08/10- CCL LABEL, ROBBINSVILLE

Present Quality Control Coordinator

• Prepare and support the SOPs for accuracy and compliance.

• Trained and maintained employees records for test method and SOP.

• Knowledge and experience with electronic document management and records management system.

• Raw Material approval, qualification/rejection.

• Manage and control the process of deviation reports for the internal and external audit.

• Approves facility and equipment qualification and commissioning documents.

• GMP and Safety training to the employees.

02/2009- CHEMO DYNAMICS, SAYREVILLE

11/02/09 Quality Control Manager

• Work closely with the chemists to ensure the quality of the work.

• Finish lab analysis in timely manner to meet the customer’s deadlines.

• Manage the time to finish the assignments in timely manner.

• Update the vice-president with the progress of the assignments.

• API method development and analysis.

• Release of CofA to the customers.

• Coordinate the instrument validation with the vendors for re-validation.

12/04 - LAVIPHARM LAB. INC., EAST WINDSOR

04/08 Held the title of Supervisor and served as auxiliary Director on multiple occasions.

• Method Validation.

• Performed routine product release testing, controlled drug testing and product stability testing.

• Updated lab from non compliance to GMP lab, calibration of equipments, training of the analyst/scientist, log book maintenance, documentation as per GMP and auditing of the lab.

• Prepared many Test Methods & SOP.

• Saved the company thousands of dollars by developing a SOP for the operation of the equipment and training all the subordinates in the calibration process of the four Dissolution Apparatus; previously, the company had been paying people not employed within the company to conduct this training.

• Managed the workflow within the team framework to ensure a higher output and faster response to product priorities by allocating the work and, if needed, working in the lab to meet the deadline.

• Maintained Receipt, Usage log and inventory of Controlled Substance/Reference Standard/Chemicals/Reagents and Equipment.

• Managed Equipment Maintenance like PM, PT, OQ, PQ calibration schedule and performed Instrument HPLC, Dissolution etc. troubleshooting and repair.

• Able to comprehend and apply good quantitative techniques to performing analytical tests, and to utilize extensive math skills to ensure correct calculations of the final result.

• Reviewed and released of the documents for Quality Assurance.

• Audited outside labs for Compliance.

• Regulated stability schedule and removal of samples tabulated by Excel data.

• Oversaw waste management.

• Method Validation of products.

• Method Development for Assay and Drug Release of many products under supervision.

04/04 - Par Pharmaceuticals, Somerset

10/04 Group Leader

• Allocated work to chemists and managed their data documentation, coordinated team projects to main high output and a deft response to product priorities.

• Maintained the Controlled Drug Weighing, distribution for analysis, stability testing and disbursement to Quality Assurance department after the completion of analysis for disposal.

• Performed troubleshooting and initial investigative work, related to out-of-specification lab results with input from senior chemists and supervisors.

• Conducted formal investigative procedures and assisted other chemists in resolving method and instrument problems.

• Performed routine product release testing, controlled drug testing and product stability testing under GMP guidelines. Routine testing supports for process validation, batch size increase, and operation equipment qualifications included.

• Maintained laboratory documentation with minute attention to details of test procedures, raw data, and final results in accordance with regulatory guidelines.

• Analysis of Release, stability products and Impurities of drug products.

10/99 - Accumed Labs Inc., Lawrenceville

04/04 Analytical Chemist

• Trained 6 Chemists for routine analysis and trained laboratory personnel in GMP requirements and instrumental/method procedures.

• Meticulously performed analyses of both fragmentary and finished products, stability, water analysis, and packing materials, and documented all results.

• Supported Research and Development Analytical Testing, and Stability testing.

• Implemented change control procedures.

• Formulated and/or assessed Standard Operating Procedures (SOP), Specifications, and Standard Test procedures and OOS results.

• Provided input on the generation of external audit responses and coordinated testing of Customer Complaint samples.

• Tabulated and catalogued records of humidity chambers.

• Prepared and maintained volumetric solutions.

EDUCATION Ph.D. in Inorganic Chemistry, India (1996)

M.S. in Organic Chemistry, India (1988)

B.S. in Chemistry & Biology, India (1986)

AWARDS & Research Fellow (P.G.I.M.E.R.), India (05/1989-08/1991)

ACHIVEMENTS Merit Fellowship Award by C.C.S.H.A.U., India

Lecturer, Guru Jambheshwar University & Dayanand Post Graduate College, India

SEMINAR Waters Seminar: Effective UPLC Implementation 12/10/2009

Waters Seminar: Developing Robust LC Methods 04/15/2010

INSTRUMENTS HANDLED:

• HPLC- Waters (Millennium, Waters) and Agilent (Chemstation)

• GC- Agilent (Chemstation)

• Dissolution Apparatus- Distek (2100 B & C)and Vankel (VK-700,7010 & 7011)

• UV/ VIS (Shimadzu & Nicolet Fischer)

• FT-IR (Perkin Elmer)

• Turbidimeter (HACH)

• Viscometer, Karl- Fischer etc.

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