MANIRAJ TIWARI
Associate Manager-QA Investigation
Ankleshwar,Gujarat
Summary
Agile and adaptable staff leader with stellar work history, motivational approach and upbeat nature. Skilled at training employees approaches to handle daily planning, scheduling and customer requirements. Managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Looking for Manager level job in Quality Assurance with a growth-oriented organization where a strong knowledge of quality assurance processes will be applied to the quality output of finished goods.
Total work experience in pharmaceutical industry: 13.3 years.
Overview
13
13
years of professional experience
5
5
years of post-secondary education
2
2
Language
Work History
Associate manager QA
Zydus Lifesciences Ltd
Ankleshwar
07.2015 - Current
- Proficient for the handling of Market compliant and customer response.
- Handling of customer and regulatory audits.
- Timely Compliance of the audit observation
- Handling of out of specification (OOS), out of trend (OOT), deviation, market complaint, incident, change control, CAPA, validation and qualification.
- Utilized data analysis tools to identify and resolve production issues for investigation and to identify the root cause.
- Handling of software like Track wise, Documentum, Zytims, Lims and SAP.
- To involve for the preparation and review of investigation reports of OOS, OOT, Market Complaint and deviation reports.
- Involved for the handling of impact assessment and Risk assessment of new products/Facility.
- Review of trend analysis reports of OOS, OOT, deviation and market complaint
- To review feasibility of proposed CAPA and ensure the verification, implementation and effectiveness check of CAPA
- To coordinate for training as and when required.
- Mentored team members to enhance professional development and accountability in workplace.
- Supervised day-to-day operations to meet performance, quality and service expectations.
- Increased employee performance and job satisfaction to strengthen retention and engagement.
- Coordinated with other departments to align production with customer requirements.
Manufacturing Executive
Alembic Panelav unit
Vadodara
12.2014 - 07.2015
- Handling of day to day documents, BMR, SOP, Logs.
- Handling of equipment like: Reactors (SSR & GLR), Sparkler Filter, Pressure Filter, Centrifuge, Dryer (FBD, RCVD, VTD, STD, RVPD), Rotavapor, ANFD, Isolator, Column, Roll Compacter, Sifter, Blender, Milling Machine, Micronizer.
- 24*7 audit preparedness for customer and regulatory audits.
- Handling of customer and regulatory audits.
- Handling of change control, validation, qualification and investigations of OOS, OOT, deviations, Market complaint and incidents.
- Managed personnel by implementing company policies, procedures, work rules.
- Updated logs and submitted timely reports detailing activities in line with regulatory standards.
- Utilized data analysis tools to identify and resolve production issues.
- Scrutinized production output and identified areas for improvement.
- Planned operations to meet established schedules, factoring in order demands and business forecasts.
- Enforced health and safety protocols to promote safe working environment.
- Coordinated with other departments to align production with customer requirements.
- Monitored inventory levels and restocking schedules to avoid production delays from unavailable materials.
- Trained in and implemented emergency response procedures to protect team members.
- Created and oversaw production schedules and adjusted as needed to meet deadlines.
- Passionate about learning and committed to continual improvement.
- Oversaw routine maintenance programs and scheduled service to keep equipment functioning at peak levels.
Manufacturing officer
LUPIN Ltd
Pithampur Indore
02.2013 - 12.2014
- Handling of day to day documents, BMR, SOP, Logs.
- Handling of equipment like: Reactors (SSR & GLR), Sparkler Filter, Pressure Filter, Centrifuge, Dryer (FBD, RCVD, VTD, STD, RVPD), Rotavapor, ANFD, Isolator, Column, Roll Compacter, Sifter, Blender, Milling Machine, Micronizer.
- 24*7 audit preparedness for customer and regulatory audits.
- Handling of customer and regulatory audits.
- Handling of change control, validation, qualification and investigations of OOS, OOT, deviations, Market complaint and incidents.
- Managed personnel by implementing company policies, procedures, work rules.
- Updated logs and submitted timely reports detailing activities in line with regulatory standards.
- Enforced health and safety protocols to promote safe working environment.
- Coordinated with other departments to align production with customer requirements.
- Oversaw routine maintenance programs and scheduled service to keep equipment functioning at peak levels.
Chemist (Manufacturing)
IOL Chemical & Pharmaceutical limited
Barnala
04.2011 - 01.2013
- Handling of day to day documents, BMR, SOP, Logs.
- Handling of all production equipment like: Reactors (SSR & GLR), Sparkler Filter, Pressure Filter, Centrifuge, Dryer (FBD, RCVD, VTD, STD, RVPD), Rotavapor, ANFD, Isolator, Column, Roll Compacter, Sifter, Blender, Milling Machine, Micronizer.
- 24*7 audit preparedness for customer and regulatory audits.
- Enforced health and safety protocols to promote safe working environment.
- Coordinated with other departments to align production with customer requirements.
Chemist (Manufacturing)
Surya Pharmaceutical limited
samba
09.2010 - 04.2011
- Handling of day to day documents, BMR, SOP, Logs.
- Handling of all production equipment like: Reactors (SSR & GLR), Sparkler Filter, Pressure Filter, Centrifuge, Dryer (FBD, RCVD, VTD, STD, RVPD), Rotavapor, ANFD, Isolator, Column, Roll Compacter, Sifter, Blender, Milling Machine, Micronizer.
- 24*7 audit preparedness for customer and regulatory audits.
- Enforced health and safety protocols to promote safe working environment.
- Coordinated with other departments to align production with customer requirements.
Education
POST GRADUATION (MSc.) -
A.P.S. University Rewa
01.2008 - 01.2010
GRADUATION (BSc.) - undefined
S.K.N.P.G. Collage Mauganj
01.2005 - 01.2008
HIGHER SECONDARY - undefined
HIGH SCHOOL - undefined
Skills
Investigation of Market complaint, OOS, OOT, deviations
undefinedAccomplishments
- I have faced USFDA audit in Zydus cadila. My role was: Explaining investigation to auditor.
- I have faced EUGMP, ANVISA, WHO, CANADIAN, TGA, 5WS and many customer Audits successfully.
- Certificate for Timely closing of investigation documents and Certificate for ICH Q7 training.
Interests
Playing Chess, Meeting new people
Personal Information
- Father's Name: Mr. R.K.TIWARI
- Date of Birth: 07/09/88
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Current Responsibilities
To investigate the out of specification (OOS), out of trend (OOT), deviation and market complaint to find out the root cause by the using of investigation tools.
To form CFT for investigation and lead the investigation.
To coordinate with different functional departments for shop floor investigation.
To ensure investigation is completed within time line.
If investigation is not completed in time, to ensure Interim Report is prepared, reviewed and request for extension is approved.
To review the investigation report for its adequacy, root cause, cause category, CAPA and recommendations, impact assessment, Risk assessment.
Review of trend analysis reports of OOS, OOT, deviation and market complaint.
To review feasibility of proposed CAPA and ensure the verification, implementation and effectiveness check of CAPA.
To coordinate for training as and when required.
Handling of customer and regulatory audits.
Timely Compliance of the audit observations.
Proficiency in handling of OOS, OOT, deviation, market complaint, incident (Investigation and root cause identification) change control, CAPA, validation and qualification.
Proficiency in handling of software like Track wise, Documentum, Zytims, Lims and SAP.
Trainings Attended
- Training on investigation techniques, Validation and ICH Q7.
- Supervisory Development Program (including sessions like Time management, Quality Circle, Communication Skill etc.) of 4 days at Ahmadabad (Gujarat).
Projects
March 2010 to June 2010: I have done Dissertation work in QC department, with ALPA ltd Pig dumber Indore
Disclaimer
I hereby declared that the above furnished information is true to the best of my belief in spirit and content and I bear all the responsibility for the correctness of the above-mentioned particulars.
Software
Track wise, SAP, Documentum, Zytims, Lims
I am a chess player
I am a chess player. I got first rank in Zydus, third rank in Alembic and second rank in college level.
Timeline
Associate manager QA
Zydus Lifesciences Ltd
07.2015 - Current
Manufacturing Executive
Alembic Panelav unit
12.2014 - 07.2015
Manufacturing officer
LUPIN Ltd
02.2013 - 12.2014
Chemist (Manufacturing)
IOL Chemical & Pharmaceutical limited
04.2011 - 01.2013
Chemist (Manufacturing)
Surya Pharmaceutical limited
09.2010 - 04.2011
POST GRADUATION (MSc.) -
A.P.S. University Rewa
01.2008 - 01.2010
GRADUATION (BSc.) - undefined
S.K.N.P.G. Collage Mauganj
01.2005 - 01.2008
HIGHER SECONDARY - undefined
HIGH SCHOOL - undefined
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