1. APPLICATION
From,
SK.Nazeer
nazeer418@gmail.com
C.NO-+91 9884718398, 9985698398
Subject: Application for a suitable position in your organization
Respected Sir,
With reference to the above-cited subject I, SK Nazeer, a Graduate in Pharmacy, Working as an
Assistant Manager (Manufacturing Remediation - Investigations) in “Hospira, A Pfizer
Company. I would like to apply in your esteemed concern. My candidature and other relevant
particulars are enclosed here with for your ready reference. For your kind reference I am here by
attaching a copy of my CV.
I hope that I will receive a favorable communication from your side.
Thanking you in anticipation.
Date:
Place: Chennai Your’s sincerely
(SHAIK NAZEER)

2. CURRICULUM VITAE
SK. Nazeer  Mobile No: +91 9884718398, 9985698398
E-mail: nazeer418@gmail.com
CAREER OBJECTIVE:
To work in an organization where I can use intellectual abilities and communication skill to
achieve objectives set by the company and helps in enhancing my technical skills in order to scale
greater heights.
PROFESSIONAL EXPERIENCE:
• Working as an Assistant Manager in Manufacturing Remediation - Investigations,
Hospira (A Pfizer Company), Chennai from Oct-2014 to till date.
• Worked as a Sr. Executive (Approved chemist) in blending & filling department,
Biological E. Limited, Hyderabad from FEB-2012 to Sep-2014.
• Worked as a Jr. Officer (Approved chemist) in formulation & filling department,
SHANTHA BIOTECHNICS LIMITED (A Sanofi Company), Hyderabad from JAN-
2008 to FEB-2012.
JOB PROFILE:
Hospira (A Pfizer Company):
 Remediation: Performed the following activities.
• Perform gap assessment between manufacturing process, written procedures and
regulatory requirements.
• Assessment of practices following in different sites and present the assessment to
management & adopt the best practices for the site.
• Revision of the procedure to fulfill the gaps and audit commitments.
• Mapping of all manufacturing areas with SOPs and work for aligning the procedures
across the site by reducing the number of procedures for similar operations through
grouping.

3.  Investigation:
Investigation of all manufacturing related deviations through “Trackwise” software that
includes (and not limited to).
• Media fill failure investigations.
• Personnel and environmental monitoring excursions.
• Excursions in room conditions (DP, RH and temperatures).
• Machine breakdowns.
• In process inspection failures, failure in yield reconciliations and packing related
deviations.
• Finished product OOS.
• Process, procedure and personnel related deviations.
 Recommendations of CAPA for the identified root cause findings.
Biological E Limited:
 Supervision of activities related to blending and filling department.
• Supervision of sterilization and final blending activities of vaccines.
• Manage the man power in a shift for optimum productivity.
• Train the man power involved in blending and filling operations for their respective
activities.
• Execution of Media fills validations, process validations and cleaning validations
• Preparation of SOPs, BPRs, protocols.
• Meet the blending and filling targets as per plan for domestic and export use.
• Monitoring of filling and sealing operations.
• In-process checking of filled & sealed vials.
• Practice and implementation of the Environmental Management Systems (EMS) and
Occupational Safety Management Systems (OSHAS).
• Rising of change controls for process changes, deviations for discrepancies and process
improvements.
• Investigation of failures in the production.
Shantha Biotechnics Limited (A Sanofi Company):
• Formulation of vaccines and therapeutics in fill finish area.
• Involving in Pre-Formulation activities, Sterilization activities.
• Involving in Aseptic Media fill Validations (Aseptic Process Simulation).
• Involving in planning and organization of Process validations, equipment qualifications.

4. • Involved in preparation and organization of training program.
• Handling all SAP-PP user transactions
• Co-ordination with QA in handling of deviations, change controls.
• Co-coordinating with QC, QA and regulatory affairs.
• Project team member for restore of DTPwH-Hib vaccine from IO-formulation.
• Project team member for HPV vaccine development from IO-fill finish.
DOCUMENTATION EXPERIENCE:
 Preparation of investigation reports based on the investigation analysis and root cause
findings.
 Develop the CAPA plans.
 Review and preparation of Process validation Protocols, Process Simulation Protocols.
 Review and preparation of BMRs, Standard Operating Procedures, Process Procedures
and Record Sheets.
 Preparation of process validation reports by compile data form validation batches.
 Handling and raising of Change Control, Deviation and CAPAs.
EDUCATIONAL QUALIFICATION:
• Pursuing M.Pharmacy from Kakatiya University at Chaitanya institute of
pharmaceutical sciences, Warangal.
• B.Pharmacy from Nagarjuna University at “Dr. Samuel George Institute of
Pharmaceutical sciences”, Markapur (2003-2007).
PERSONNEL DETAILS:
Name : SK. Nazeer
Father’s Name : Rahamathulla
Marital Status : Married
Nationality : Indian
Language Known : English, Telugu and Hindi.
DECLARATION
I here by declare you that the information given in this document is true to the best of my
knowledge and belief.
Date: Your’s sincerely
Place: Chennai (SHAIK. NAZEER)