xxx-xxx-xxxx 16 rolling brook drive - edison, nj 08820 abc@xyz.com

yyyyyy x. yyyyyy

yyyyyy x. yyyyyy

pharmaceutical quality assurance specialist with dynamic management, team building and process enhancement skills as well as extensive knowledge of regulatory compliance issues eager to contribute talents toward supporting a progressive organization in maximizing performance

profile

ø  offer solid experience in pharmaceutical quality assurance, including extensive experience in developing innovative qa procedures and benchmarking.

ø  effectively define, develop and implement targeted action plans to maximize operational productivity, efficiency and profitability.

ø  proactive leader who successfully trains/develops, mentors and leads top-performing teams committed to providing superior service.

ø  dynamic communication, presentation, relationship building and problem-solving abilities.

ø  excel at interacting with broad populations including senior management, sales and customer service staff as well as clients and external contractors.

ø  proven ability to complete projects in record time while exceeding all gmp requirements and regulatory compliance.

areas of expertise

         quality systems creation                 validation                                            compliance/sterile manufacturing

         batch record review                      investigations (capa)                          team building/training

         drug product release                     change control                                    presentations/lectures

career achievements

  significantly increased the number of direct and indirect reports in qa from 1 to 18 over a period of 3 years tripled and job responsibilities, with 18 reports since february 2006.

  consistently improved the batch release time to 99% release in most optimal target time of 1 business day and maintained it over the years.

  successfully improved customer complaints procedure and the response time by over 100% in 1 year, with continued improvements every year.

  efficiently used benchmarking in all 7 years with qa to continuously improve the procedures and processes showing improvements in standards and timelines.

  saved substantial money and efforts for the company by writing scientific and risk-based process validation justifications for a protein formulation towards nda.

  presented pharmaceutical process development lectures for the center for professional advancement in east brunswick, new jersey in 2005.

  published in reputable pharmaceutical research journals.

professional experience

organon usa inc. (part of schering-plough corp. starting 2007) - roseland, nj                     1998-present

director - release coordination qa, organon (2002-present)

  proficiently conduct thorough batch record reviews and responsible for drug product releases.

  proactively interface with clients to address and resolve any product/service issues, ensuring high levels of satisfaction and retention.

  conduct comprehensive review and analysis of investigation reports, change controls, validation reports, post-marketing stability reports, external manufacturers quality agreements and annual product review reports.

  apply scientific and regulatory expertise toward overseeing all aspects of quality and manufacturing operations; relied upon as subject matter expert in sterile manufacturing operations.

 

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vinod gupta, ph.d.                                                                                                                                   page 2 of 2

 

 

organon usa inc. - roseland, nj                                                                                        1998-present

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manager - manufacturing technology department, organon (1998-2002)

  maintained full accountability for overseas transfer projects involving process, equipment, and validation, with most projects involving sterile drug products.

  directly led and supervised majority of projects to tracking within record time, receiving management commendations and awards, as well as fda approval.

  exhibited industry knowledge and communications abilities in effectively writing numerous stability reports and conducting variety of manufacturing process validation studies.

 

additional experience

 

rutgers university - piscataway, nj                                                                                     1993-present

adjunct assistant professor - sterile manufacturing (2001-present)

teaching assistant - pharmaceutical manufacturing/calculations & pharmacokinetics (1993-1998)

 

birla institute of technology & science - pilani, india                                                             1992-1993

assistant lecturer - pharmacy & molecular biology

education

ph.d. in pharmaceutical sciences - rutgers university (piscataway, nj), 1998

masters in pharmacy - birla institute of technology & science (pilani, india), 1991

masters in management studies - birla institute of technology & science (pilani, india), 1986

bachelors in pharmacy - birla institute of technology & science (pilani, india), 1984

professional affiliations

american association of pharmaceutical scientists (aaps), 1995-present

parenteral drug association (pda), 1999-present; member of letter editorial committee since 2005

american society for quality (asq), 2002-present