Tyla Mahon is a senior at Southern New Hampshire University who interned with Pfizer's PharmSci QA group in Andover, MA for the summer of 2015. During her internship, she gained exposure to various roles through projects involving internal auditing, records management, and CAPA. She helped organize a student tour and contributed to the Women's Leadership Network. The internship provided valuable lessons about teamwork, communication, and quality culture in the pharmaceutical industry.
Chelumala Revanth is seeking a challenging position in clinical research. He has over 2 years of experience as a Clinical Research Associate at CRBIO, where his responsibilities include supervising registration and screening, volunteer database maintenance, informed consent activities, dosing, compiling trial master files, and quality control. He has a BPharm degree and postgraduate diploma in clinical research and data management. His technical skills include Microsoft Office and he has participated in workshops on clinical research and evidence-based pharmacy education.
This document provides an overview of the course materials for HCS 451, including discussion questions, assignments, and tutorials. It outlines the key topics covered in each week, such as risk management, quality management, and organizational performance. Assessment summaries and management plans are assigned relating to these topics. Students also complete a table comparing healthcare organization types and a presentation analyzing quality metrics. The course emphasizes applying concepts like regulatory compliance, risk analysis, and process improvement to healthcare settings.
This letter recommends Mr. Belal Hossain for employment. It details that Mr. Hossain worked as a microbiologist for CHRF in Bangladesh from 2005 to 2014 under the direct supervision of the author. The letter describes Mr. Hossain as a very capable employee who took on increasing responsibilities over time, including coordinating projects, writing proposals and reports, and data analysis. It highlights his strong leadership, logical thinking, ability to work well in a team, and promoting skills. The author expects Mr. Hossain to be a positive addition to any institution.
Shivaan Cooppan is a Production Pharmacist at Ranbaxy-Be-Tabs in Johannesburg, South Africa. He has held this position since July 2012, where he oversees the manufacturing of medications. Some of his accomplishments include successfully auditing for GMP compliance from 2012-2014, creating standard operating procedures and tracking systems, and reducing rejected batches due to process errors. Prior to his current role, Cooppan worked as a Community Service Pharmacist from June 2011-June 2012 and did a pharmacy internship from October 2010-January 2011 to complete his education and training.
Kristy Coonen is seeking a position in healthcare that utilizes her skills in leadership, development, problem solving, and quality improvement. She has over 10 years of experience in healthcare settings including as a Medication Reconciliation Specialist at Thedacare, a Certified Pharmacy Technician at Thedacare and Walgreens, and a Dietary Food Aid. She has a Bachelor's Degree in Science and Health Care Administration from the University of Phoenix and certifications as a Pharmacy Technician and in BLS.
The document outlines Pfizer's vision, mission, values, and strategies. It discusses Pfizer's commitment to improving health and helping patients live longer lives through innovation. It also summarizes Pfizer's key values of integrity, respect, customer focus, community involvement, innovation, teamwork, performance, leadership, and quality.
Chelumala Revanth is seeking a challenging position in clinical research. He has over 2 years of experience as a Clinical Research Associate at CRBIO, where his responsibilities include supervising registration and screening, volunteer database maintenance, informed consent activities, dosing, compiling trial master files, and quality control. He has a BPharm degree and postgraduate diploma in clinical research and data management. His technical skills include Microsoft Office and he has participated in workshops on clinical research and evidence-based pharmacy education.
This document provides an overview of the course materials for HCS 451, including discussion questions, assignments, and tutorials. It outlines the key topics covered in each week, such as risk management, quality management, and organizational performance. Assessment summaries and management plans are assigned relating to these topics. Students also complete a table comparing healthcare organization types and a presentation analyzing quality metrics. The course emphasizes applying concepts like regulatory compliance, risk analysis, and process improvement to healthcare settings.
This letter recommends Mr. Belal Hossain for employment. It details that Mr. Hossain worked as a microbiologist for CHRF in Bangladesh from 2005 to 2014 under the direct supervision of the author. The letter describes Mr. Hossain as a very capable employee who took on increasing responsibilities over time, including coordinating projects, writing proposals and reports, and data analysis. It highlights his strong leadership, logical thinking, ability to work well in a team, and promoting skills. The author expects Mr. Hossain to be a positive addition to any institution.
Shivaan Cooppan is a Production Pharmacist at Ranbaxy-Be-Tabs in Johannesburg, South Africa. He has held this position since July 2012, where he oversees the manufacturing of medications. Some of his accomplishments include successfully auditing for GMP compliance from 2012-2014, creating standard operating procedures and tracking systems, and reducing rejected batches due to process errors. Prior to his current role, Cooppan worked as a Community Service Pharmacist from June 2011-June 2012 and did a pharmacy internship from October 2010-January 2011 to complete his education and training.
Kristy Coonen is seeking a position in healthcare that utilizes her skills in leadership, development, problem solving, and quality improvement. She has over 10 years of experience in healthcare settings including as a Medication Reconciliation Specialist at Thedacare, a Certified Pharmacy Technician at Thedacare and Walgreens, and a Dietary Food Aid. She has a Bachelor's Degree in Science and Health Care Administration from the University of Phoenix and certifications as a Pharmacy Technician and in BLS.
The document outlines Pfizer's vision, mission, values, and strategies. It discusses Pfizer's commitment to improving health and helping patients live longer lives through innovation. It also summarizes Pfizer's key values of integrity, respect, customer focus, community involvement, innovation, teamwork, performance, leadership, and quality.
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2) The second project involved attending meetings in New York to help with the Global Quality Redesign process and network with US colleagues, resulting in new collaboration software.
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Hollie Peterson completed a spring 2017 internship at the Greenville Health System Center for Integrative Oncology & Survivorship (CIOS). She achieved her goals of enhancing her professional skills, gaining knowledge of patient flow and care, and understanding the impact of CIOS' holistic programs. One of her projects was creating provider resource binders, which organized educational materials for providers to use during patient visits. Peterson contributed significantly to CIOS through various projects and tasks. Her experience reinforced her career goal of working in a field that integrates holistic health services.
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- Additional duties included attending community events, health fairs, and analyzing data from presentations.
- The internship helped develop the author's knowledge of skin cancer and how a non-profit health organization operates.
- Feedback suggests preparing future interns to help update educational materials for different audiences.
Apoorva Sharma has over 4 years of experience in medical expert management, clinical trial management, and clinical development support. She has worked at Novartis in India supporting their cardiovascular, osteoporosis, and neurosciences divisions. Her responsibilities included developing relationships with medical experts, gathering competitive information, assisting with regulatory submissions, and monitoring clinical trial sites. She also worked as a therapy specialist at BBraun Medical in India, where she helped roll out certification courses and develop business strategies.
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1. PharmSci QA Summer Student Worker 2015
Tyla Mahon
Andover, MA
ABSTRACT
My name is Tyla Mahon and I will be a senior this
upcoming fall at Southern New Hampshire University
(SNHU). At SNHU, I was selected to be part of an
integrated business program called Degree in Three. I was
included in the pilot group of students that SNHU has
welcomed to the program. It is an unique experience
because the program is solely business orientated,
incorporating all of the core curriculum into the major
classes, allowing us to graduate with all of the collegiate
requirements met in just three years rather than the
standard four year Bachelor’s degree.
I have always admired what Pfizer has stood for and it
gave me a great interest in the industry. During my second
year at SNHU I learned of the opportunities Pfizer offers
for students and I applied for a Summer Student Worker
position for the 2015 summer. I then was chosen to
support the Pfizer Andover, PharmSci QA group under the
management of Denise Gleich.
It has truly been an honor to be a part of Pfizer
Andover’s team this summer. Not only have I enjoyed
every day of it, but I have learned more than I could’ve
imagined. The opportunities that I have experienced have
served to educate me on working in a large corporation,
but has also exposed me to experiences and networking
that I would never have imagined.
Internal Audits
With Theresa McCarthy
• While working with Theresa I got to experience a side
of the company that many people do not. Internal
Auditing is a crucial part of Pfizer. Auditors ensure that
employees have the required training to perform their
job. In addition, auditors verify that the procedures
employees use to meet the requirements of board of
health around the world where Pfizer sells their
products (e.g. U.S.-FDA)
• I was able to assist Theresa in many situations such as:
preparing minutes for the Software Medical Device Site
Quality Review Team, developed the Agenda for the
Global Biotherapeutics Analytical Quality Council, and
developed an Internal Audit Plan and Checklist for
Andover Liquid Dose Manufacturing Facility
• Other activities included; posting Regulatory
Intelligence to the Compliance Intelligence Alert (CIA)
SharePoint, updating the Risk Register and mitigation
plan as well as attended the Audit Inspection
Compliance Effectiveness (AICE) Team Meeting.
AWARDS
During my time here at Pfizer I was awarded an
Andover Quality Culture Recognition Award. This
award was presented by Laura White for Recognition
of Strong Quality Culture Behavior while working on a
CAPA project to help not only Andover, but the Groton,
St. Louis, and Sandwich sites as well.
“Your resourcefulness has helped QA in Andover, St.
Louis, Groton and Sandwich to determine the
appropriate QA contact. Your collaboration has
helped QA at various locations to collaborate on this
CAPA. Thank you.” –Laura White
Key Learnings
My biggest take away from Pfizer Andover is how
essential teamwork and collaboration is. It is crucial
that Pfizer employees work as a team Lack of
communication can lead to detrimental
consequences for not only Pfizer, but to customers
across the world.
I was very lucky to be able to shadow and
experience many different positions that employees
hold here and how they all play a role in the
manufacturing of our products.
My appreciation for, not only the Pharmaceutical
Industry but for, business itself has grown
immensely. As a business major, I have seen
firsthand how safety, teamwork and integrity can
affect a company and I am beyond grateful that I
can take back to school what I have learned here at
Pfizer Andover. I now have the opportunity to share
this experience with my business studies at
Southern New Hampshire University.
Record retention, GDMS & archival of GMP
records
With Veronica Chamberland
This summer I had the pleasure of working with Veronica
under Denise Gleich. My Primary responsibilities included
uploading scanned copies of Master Batch Records and
Manufacturing Batch Records into the Global Document
Management System (GDMS) and archiving records for
long term storage. This project was a critical aspect of
doing business here at Pfizer, because we manufacture
drug product, our records are regulated by the Food and
Drug Administration (FDA). I processed a large volume of
work in a short period of time by entering data into
spreadsheets and uploading scans, making document
retrieval easier for employees around the world going
forward.
I also had the opportunity to spend time with the Quality
Culture Group. During which I took meeting minutes for
the Calibration Risk Exercise in Andover. I then
collaborated with all PharmSci Sites to combine all the
information from the Calibration Risk Exercise and I
published the results on the Quality Culture SharePoint
site.
PALS Tour
With Jen Sloan
Here I helped organize and execute a student tour for the Phillip
Exeter’s Performing Artists at Lincoln School (PALS) Program.
PALS is made up of students from the Leonard and Parthum
Middle Schools in neighboring Lawrence, MA, and the goal of the
PALS program is to expose the children to special tutoring and
academics, and give them the skills and support that they need to
stay in school and attend college.
- These students are hand selected by their teachers to participate in this
two year mentoring program due to their good academic and behavioral
standing. Many of these students are the children of immigrants, and
would be the first in their families to attend college.
I was able to assist this program by escorting a group of 12
students through the BRD lab and Pilot areas. Andover has been
providing a ½-day science related field trip to these students for
the past seven years.
WLN
Women's
Leadership
Network
Internal
Audits
GDMS
CAPA
1053880
PALS
Tour
Projects
CAPA 1053880
With Laura White
I also had the pleasure to work on a Corrective Action
Preventative Action (CAPA) for Laura White. This
particular CAPA involved both Pharmaceutical
Therapeutics Pharmaceutical Sciences (PTx PS) and
Biological Therapeutics Pharmaceutical Sciences and
(BTx PS) products. My task was to research and review a
list of 112 product records obtained from Clinicopia. Many
of these records needed some gaps filled and more
specifically needed the description updated.
I performed an assessment of the PTx and BTx excel
record containing the DMID numbers and the descriptions
and performed a comparison study against the product
records to identify gaps between them and then I filled all
of the gaps completing the product records. Some of the
gaps we not easily filled as many were not in either of the
data samples so I had to research and navigate through
the BTx SharePoint and Carol Bye’s SharePoint to
determine who the QA representative was for each of the
112 items. I then looked at BTx projects lead file and
found the products and filled in the representatives from
different business units.
This process took several days, but will help many QA
representatives from different Pfizer sites for a long time
to come.
Women’s Leadership Network (WLN)
With Theresa McCarthy and Veronica Chamberland
When working with WLN at Pfizer I was able to help by
supporting the Women’s Leadership Network Lunch and
Learn, which had an amazing attendance of over 60 people.
I also attended monthly meetings in which we discussed
current and future WLN events for the upcoming year.