Summary
Overview
Work History
Education
Skills
Roles And Responsibilities -Primary
Qualityengineering-Secondary
Accomplishments
Field Of Interest
Languages
Personal Information
Hobbies and Interests
Disclaimer
Timeline
Generic

FATHE MOHAMMAD SHAIK

Hyderabad

Summary

I would like to be in a position in an organization that seeks an ambitious and career-conscious person where acquired technical skills, industrial experience, and professional education will be utilized towards continuous organizational growth, personal growth as well as the advancement of the organization. Forward-thinking professional with proven history of leadership, planning and problem solving. Adept collaboration with professional to accomplish demanding objectives, motivate staff, and organize resources. Systematic understanding of maintaining coverage for all operational needs.

Overview

9
9
years of professional experience

Work History

Asst. Manager

CRONUS PHARMA PVT LTD
08.2020 - 02.2022

Executive

SUN PHARMA LABORATORIES LIMITED
05.2019 - 10.2019

Senior Executive

CRONUS PHARMA PVT LTD
02.2018 - 05.2019

Senior Executive

VIRCHOW BIOTECH PVT LTD
04.2017 - 02.2018

Asst. officer

NATCO PHARMA LIMITED
03.2015 - 03.2017

Trainee officer

GLAND PHARMA LIMITED
02.2013 - 02.2015

Asst. Manager

AET LABORATORIES ( Group)
02.2022

Education

B.Tech -

JNTU KAKINADA
01.2010

BOARD OF INTERMEDIATE -

Krishnaveni Junior College
01.2006

BOARD OF SECONDARY EDUCATION (S.S.C) -

NRHS School
01.2003

Skills

  • Sound knowledge in MS- Office
  • Boiler and Steam Distribution Line Certification
  • Track wise
  • MS projects scheduling
  • comissioning and qualifications

Roles And Responsibilities -Primary

  • Involve in commissioning and qualifications of HVAC-BMS & EMS ,Clean utilities process equipments for the pharmaceutical facility which includes injectable/OSD/oncology /sterile dry powders/cephalosporin sterile .
  • Responsible for preparation /reviewing. of qualification protocols for HVAC-BMS & EMS ,Clean utilities process equipments .
  • Responsible for preparation of standard operating procedures for equipment operation and preventive maintenance.
  • Responsible for onsite support C&Q activities by following ISPE/ASTM methodologies utilizing GDP,GEP,C&Q Base line guides GAMP5 & cGMP Principles.
  • Responsible for preparation and review of Validation Master plan,Validation plans,Validation Documents,Commissioning and Validation Execution of Clean Rooms ,HVAC systems,Clean Utilities,Process Equipments(such as DQ,IQ,OQ,PQ)as per the pharmaceutical Industrial practices
  • Responsible for Preparation and execution of pre commissioning & commissioning various systems including facility and process/Utility equipments
  • Monitoring all HVAC systems operational records and preventive maintenance records and yearly schedules.
  • Responsible for periodic qualification and requalification protocol preparation and execution in the HVAC system.
  • Planning, scheduling, and implementation of PM activities for all AHUS, LAF, PASS BOX, BMS.
  • Responsible to execute the yearly alarm challenge & interlocks verification, for process equipment's.
  • Preparation and Execution of facility,Utility & process Equipments URS/FAT/SAT/Reports.
  • Coordination with internal stake holders( such as production quality assurance )to execute qualifications in complains deliverables.
  • Knowledge in regulatory guidelines-USFDA,MHRA,WHO,ISO,21 CFR part 11 and other regulatory guidelines.
  • Responsible to look after oncology isolators operations, preventive maintenance and qualifications, requalification's, preventive maintenance.
  • To look after OSD process equipment's qualifications and requalification's like granulations machine, tablet compression machine, coating machine.

Qualityengineering-Secondary

  • Developing the Quality improvements works as per CGMP
  • Preparation of audit compliance reports and CAPA.FEMA. And quality engineering aspects.
  • To develop and implement quality programs, including tracking, analyzing, reporting, And problemsolving.
  • Involve project to check and ensure the documents like URS, FAT, DQ, SAT, IQ, OQ, and PQ as per engineering complies.
  • To look after engineering documentation compliance like DEVIATION and CAPA, CHANGE CONTROLS, BREAKDOWNS, and HISTORY CARDS.
  • Hands-on experience in Risk Management, Design Controls.
  • Quality Risk Management (Assessment, Control & Review) throughout the life cycle as per ICH-Q9.
  • Follow GEP in daily work culture to build enhance performance and efficacy of equipment, system, and organization.
  • Engagement with project & maintenance teams to identify Quality, Compliance issues, provide CAPA, and track them down for closure.
  • GAP Analysis/assessment of legacy system as per various regulatory requirements.
  • Preparation and execution of mitigation or remediation plan to close identified Gaps within the stipulated time frame.
  • To coordinate with project stakeholders for overall qualification-related activities.
  • Participate in cross-functional teams to develop equipment risk management files (risk management plan, risk assessments, and risk management report.
  • Develops templates and training based on the quality system regulations, applicable standards, and guidance.
  • Equipment and utility Qualification.
  • To adhere to the ALCOA & ALCOA PLUS with ethical and moral values as per the regulatory as well as organizations requirements.
  • SME for regulatory audits in engineering QMS.

Accomplishments

  • Within the target time line closure completed the HVAC ,EMS ,Pw Generation comissioning and qualifications in NATCO Pharma limited.
  • Within the target time line closure completed the HVAC ,BMS -EMS ,PW, WFI, PS PHASE -1 qualifications in Cronus Pharma Specialties India private limited.
  • Attended internal auditor training in sun pharma laboratories Mumbai.
  • Within the stipulated time completed the oncology blcok comissioning and qualification at aet laboratories.
  • involve in on going projects of oncology expansion commissioning and qualifications in aet laboratories

Field Of Interest

  • Quality engineering.
  • Audit compliance and documentation.
  • QMS Engineering Compliance.
  • Projects and qualifications.

Languages

Telugu
First Language
English
Upper Intermediate (B2)
B2
HINDI
Proficient (C2)
C2

Personal Information

  • Date of Birth: 12/31/1986
  • Nationality: Indian
  • Marital Status: Married

Hobbies and Interests

playing cricket, sining songs and gazals

Disclaimer

I hereby declare that all the particulars furnished by me are in this application are true correct and complete to the best of my knowledge and belief.

Timeline

Asst. Manager

AET LABORATORIES ( Group)
02.2022

Asst. Manager

CRONUS PHARMA PVT LTD
08.2020 - 02.2022

Executive

SUN PHARMA LABORATORIES LIMITED
05.2019 - 10.2019

Senior Executive

CRONUS PHARMA PVT LTD
02.2018 - 05.2019

Senior Executive

VIRCHOW BIOTECH PVT LTD
04.2017 - 02.2018

Asst. officer

NATCO PHARMA LIMITED
03.2015 - 03.2017

Trainee officer

GLAND PHARMA LIMITED
02.2013 - 02.2015

B.Tech -

JNTU KAKINADA

BOARD OF INTERMEDIATE -

Krishnaveni Junior College

BOARD OF SECONDARY EDUCATION (S.S.C) -

NRHS School
FATHE MOHAMMAD SHAIK