This document provides a summary of Manoj Kumar Parida's professional experience and qualifications. It lists his current role as Senior Manager of Quality Control (Microbiology) at Emcure Pharmaceuticals Ltd. It then outlines his 16 years of experience in microbiology roles at various pharmaceutical companies. The document details his responsibilities in directing microbiology laboratories and ensuring compliance with regulatory standards.

1. MANOJ KUMAR PARIDAMANOJ KUMAR PARIDA
Contact: +91- 9168781975 / +91- 9049001909
Email: manoj.parida29@gmail.com., manojkparida@rediffmail.com,
Address: Sanskriti Society, C-908, Kaspate Basti, Wakad, Pune ,
Maharastra, Country: India. Pin Code: 411057.
QC / QA PROFESSIONALQC / QA PROFESSIONAL
Presently working as Sr. Manager Quality Control (Microbiology) in Emcure Pharmaceuticals
Ltd. Plant III, Hinjawadi, Pune-411057, Maharastra.
Approved Microbiologist having 16 years of experiences in Formulation (Tablet, LVP, SVP,
Lyophilized Injection and Liquid oral) and Medical Device (Coronary Stent System, PTCA
Catheter, PTCA Guide Wire) manufacturing industry.
PROFESSIONAL EXPERIENCEPROFESSIONAL EXPERIENCE
• Organization: Emcure Pharmaceuticals Ltd. Plant III, Hinjawadi, Pune-411057,
Maharastra.
Designation: Sr. Manager Quality Control (Microbiology).
Organization Profile: Manufacturing the Cytotoxic injections (Liquid and Lyophilized
Injections). The facility is accredited by regulatory agencies like
MHRA, TGA and Health Canada and WHO etc.
Duration: From Feb. 2016 to till date.
• Organization: VHB Medi Sciences Ltd. SIDCUL, Uttarakhand-263145.
Designation: Manager Microbiology.
Organization Profile: Manufacturing the Cytotoxic injections (Liquid and Lyophilized
Injections), Hormonal Injections, Cephalosporin injections (Dry
powder injections) and General injections (Dry powder Inj. and
Liquid Injections).The facility is accredited by MOH - Namibia,
Syria, Nepal, Saudi Arabia, Kenya, Malawi, Iraq, Tanzania and
WHO etc.
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2. Duration: From Dec. 2014 to Jan. 2016.
• Organization: Cipla Ltd. Sikkim-737133.
Designation: Department Head (Management Staff) in Microbiology Department.
Organization Profile: Dry Powder Injection, Tablets, Capsules, Dry Syrups, Rediuse,
Oral liquid and Topical preparations. The facility is WHO GMP
certified unit catering to the domestic market.
Duration: From Dec. 2012 to Dec. 2014.
• Organization: Meril Life Sciences Pvt. Ltd. Muktanand Marg, Chala,
Vapi – 396195, Gujarat.
Designation: Asst. Manager
Organization Profile: Class III Medical Device (Coronary Stent System, PTCA Catheter,
PTCA Guide Wire). The plant is domestic and export oriented unit
having approval of regulatory agencies like: USFDA and CE etc.
Duration: From Apr. 2008 to Nov. 2012.
• Organization: Khandelwal Laboratories Pvt. Ltd, Dadra Unit. D&NH. – 396191
(U.T.).
Designation: QA Officer.
Organization Profile: Tablets, Capsules, and Small Volume Parentral Formulations. The
facility is WHO GMP certified unit catering to the domestic market.
Duration: From Jun.-2006 to Apr.-2008.
• Organization: Bliss Infusions and Surgical Pvt. Ltd. Nashik – 422007,
Maharashtra.
Designation: Senior Microbiologist in Microbiology Department.
Organization Profile: Small & Large Volume Parentral, Liquid oral formulations. The
facility is WHO GMP certified unit catering to the domestic market.
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3. Duration: From Feb. 2003 to May. 2006.
• Organization: Vital Health Care Pvt. Ltd. Nashik – 422007, Maharashtra.
Designation: Microbiologist in Microbiology Department.
Organization Profile: Small Volume Parentral, Sterile ointment formulations. The facility
is WHO GMP certified unit catering to the domestic market.
Duration: From Jun. 2000 to Jan. 2003.
JOB PROFILE / RESPONSIBILITIES- LABORTORY FUNCTIONS:JOB PROFILE / RESPONSIBILITIES- LABORTORY FUNCTIONS:
• Directing the activities and supervising a staff of 25 individuals (microbiologists) that
monitors the microbiological quality of products and production clean areas within the
facility.
• Representing the site in all regulatory inspections such as WHO, MHRA, TGA and Health
Canada and third party inspections related to Microbiology, Environmental Monitoring and
compliances.
• To establish personnel and equipment which is required for microbiological functions.
Prepare appropriate justifications for fulfillment of these requirements.
• Ensuring that all activities of the laboratory related to functional area are executed in a
timely and efficiently by scheduling, planning, and coordinating the activities.
• To ensure that each and every activity is carried out as per standard procedures.
• Managing microbiological technical resources to determine conformance to product quality
requirements.
• Analyze and solve problems dealing with complex laboratory and production data to
determine validity and reliability.
• Provide microbiological expertise for problem solving and decision-making by plant
management.
• Communicate with employees from other facilities including R & D to assure agreement of
test methods and quality of raw materials and finished product.
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4. • Responsible for training and development of personnel, including mid-year/yearly
evaluations, mentoring, and assuring staff remains current in all new microbial
technological trends and compendia requirements.
• Responsible for development of all microbial protocols and defining validation
requirements for microbial related validations.
• Monitoring and conducting equipment, instrument and process validation as per the
regulatory and compendia requirements.
• Monitoring and conducting aseptic process simulation studies by media fills.
• Installation and qualification of laboratory equipments and instruments. Prepare and
review of URS, IQ, OQ, PQ and SQ of all laboratory instruments / equipments.
• Maintain the laboratory according to cGMP & GLP requirements.
• Self inspection of the laboratory and aseptic manufacturing areas.
• Monitoring and review of all the activities in the laboratory.
• Reporting and investigation of Incident, Change Controls, CAPA, OOT, OOS, OOAL &
OOAC results.
• Maintain the inventory of media & accessories in the laboratory. Develop and administer
expense and capital budgets to remain within spending constraints.
• Review of analytical method validation protocols and reports. Conducting analytical
method validations as per the pharmacopoeial and non pharmacopoeial methods.
• Prepare and review process validation and hold time study protocols and reports.
• Prepare and review cleaning validation exercise with respect to microbiological part.
• Monitoring and review of calibration and AMC of laboratory instruments and equipments.
• Review and implementation of specifications, IOP, EOP, SOP.
• Review of records related to the environmental monitoring in sterile manufacturing facility.
• Review of analytical results (microbiologically) to ensure that all products meet
specifications prior to authorizing release into the market.
• Preparation/review of job responsibilities of individual analyst of analytical group as well
as Non-routine group.
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5. • Responsible for evaluating the GAP’s related to sampling, analysis and release of RM, PM,
FP and miscellaneous samples with concern departments on weekly basis.
• Organizing training related to microbiology in shop floor to develop the inter personnel
skills.
• Responsible to handle all microbiology laboratory documents control, retention and their
destruction as per Quality Procedure.
• Validate all steam sterilization and Dry heat sterilization from initial installation.
• Stability study management design for finished product and raw materials. Preparation of
stability schedule, protocol, report and data analysis as per ICH guideline.
• All planning and execution of microbiology activities define the quality objectives for
system suitability. Periodically data analysis, verification and schedule preparation with
good strategies.
• All process control like process validation, cleaning validation, gowning process validation,
media fill and other validations as per the process requirements. QMS through the SAP
advanced (QM module).
• New microbiology LAB designing (MLT, Sterility and culture handling are) : HVAC layout,
Arae layout for process flow and Qualification DQ, IQ, OQ & PQ.
• Calibration & validation: All instrument calibration and equipment validation in
microbiology laboratory.
• Worked as corporate microbiology reviewer and internal auditor.
JOB PROFILE / RESPONSIBILITIES- QA FUNCTIONS:JOB PROFILE / RESPONSIBILITIES- QA FUNCTIONS:
• Regulatory compliance: Managed and comply with the Quality Manual, Quality
Management System, Quality Management Policy, Quality Objectives and applicable rules
and regulations like 21 CFR part 210 & 211, 21 CFR part 820 and EU GMP Vol – 4.
• Support to compliance/ closure of regulatory and Quality requirements as per USFDA,
MHRA, TGA, Health Canada, WHO, ISO 11137 audits before completing Design outputs/
program deliverables. As auditee during all regulatory audits.
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6. • Complete all quality plan & compliance training within the defined deadlines with technical
identification and reporting of any quality or compliance concerns to take the immediate
corrective actions as required.
• Participate in continuous improvement of cGMP and cGLP activities by identifying and
appropriately escalating process and product quality gaps providing solutions when
possible and zero defect project achievement. Key performance indicator (KPI) report to
analyze the trends and plan feature course of action.Kaizen team member for good quality
implementation by PDCA.
• Equipment qualification schedule and protocols, URS, DQ, IQ, OQ, PQ and etc.
• Preparation and review of all master documents (SOP’s, STP’s, Specifications, Test data
sheet, Master validation protocol’s, Batch manufacturing/ Packing record, Master formula
record and other quality system related documents).
• Member of self inspection team and in-house validation team. Responsible for QC/ QA
activities. Lab review, GLP review, report review and compliance etc. and APQR
preparation and in-process quality assurance at shop floor.
• Preparation of CAPA reports, compliance and closure. Handling of change control, OOS
and Deviations, preparing the investigation reports of the same and classification,
implementation, compliance and close monitoring of the trend for evaluation.
• Directing and supervising the validation & calibration activities in sterile manufacturing
facility.
• Investigation of all manufacturing process, microbiology OOS, OOT, CAPA and quality
improvement program implementation compliance team.
• Design the risk management and design development for sterile product.
• Experience in developing, updating and reviewing Quality Systems.
• Facilitate major/critical manufacturing and/or laboratory investigations (Deviations, OOS,
OOT, OOAL and OOAC).
• Participate in the development and maintenance of corporate/site policies and procedures.
• Facilitate QA rounds in the sterile manufacturing facility to ensure cGMP compliance.
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7. • Authored and reviewed change controls, deviations, procedures and product related
investigations.
• Experience in successful implementation of corrective and preventive action program
(CAPA) in dealing with deviations and complaints.
• IPQA, Issuance of BMR, APQR, Trends (Water and EM) preparations.
• Dealt with the Scheduled/ Non-scheduled Training. Internal Quality Audit (Self-
inspection).
• Responsible for the preparation and review of Annual Product Quality Review report.
• Vendor qualification; Vendor development, Vendor audit and third party audit for pharma
primary packaging material and third party testing laboratory.
NOTABLE ACHIEVEMENTSNOTABLE ACHIEVEMENTS
• Successfully faced the MHRA audit on 14th
Mar 2016 - 16th
Mar 2016 (Auditors: Mr. Norman
Gray, Mr. John Clarke and Mr. Graham Carroll).
• Successfully faced the TGA audit on 14th
Jun 2016 - 17th
Jun 2016 (Auditors: Mr. Neale
Baldwin and Mr. Danny Hawke).
• Successfully faced the Health Canada audit on 14th
Jun 2016 - 18th
Jun 2016 (Auditors: Mr.
Anthony Ashagbley and Mr. Kent Downing).
• Approved as competent Technical Person in Microbiological & Sterility Analysis from Food
& Drugs Administration, Nashik, Maharastra.
• Approved as competent Technical Person in Sterility Testing from Food & Drugs
Administration, Valsad, Gujarat.
• Audits Faced: 1) US FDA, 2) ANVISA, 3) SA MCC, 4) TGA 5) Health Canada 6) MHRA 7)
WHO GMP & 8) Several Vendor inspections.
• Attended the India Seminar 2012 At Mumbai on “The A to Z’s of Microbial Control,
Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems” by Dr. Teri
C. Soli the author of USP Chapter <1231> Water for Pharmaceutical Purposes on 29th
and
30th
October, 2012.
• Expertise in setting up new microbiology laboratory facilities.
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8. • Technical support with respect to microbiological expertise to Regulatory and Quality
Assurance Departments.
• Installation and qualifications of manufacturing process and testing equipments such as
Autoclave, DHS, Incubators, Steripump, Media preparator & Water Systems etc.
• Worked as a Core Team Member for the successful and precise implementation of QM
Module of the SAP Mount Everest project.
• Worked in the US FDA Project for Xpedient TM
PTCA Balloon Dilatation Catheter.
• Worked in the Project “Embolic Solution” used for the treatment of Embolism.
• Certified by Salesworth India Private Limited to perform the “Confirmation of Lysate
Sensitivity Assay, Standard Curve and Gel Clot Limit Test, Routine Product Testing” by Mr.
Rajesh Puthiya on 14th
May 2008.
• Successfully completed “Technical Training Course on WHO- GMP Aspects” by Late Dr. G.
L. Jain on 05th
September 2008.
• Successfully completed “Technical Training Course on Quality Assurance Concepts” by
Late Dr. G. L. Jain on 06th
September 2008.
• Completed/Passed the ongoing assessment and examination on “Advanced training on
integrated management system”. Courses covered:
Practical Auditing of:
☼ Integrated Management System according to:
☼ ISO 9001:2008, ☼ ISO 13485:2003 ☼ ISO 19011:2002
☼ ISO 14001:2004, ☼ OHSAS 18001:2007
• Worked as a Core Team Member for the successful and precise implementation of QM
Module of the SAP magni5 project.
• Successfully completed training on “CE Marking certification of Medical Devices as per
MDD 93/42/EC & USFDA Approval for Medical Devices”.
EDUCATIONAL CREDENTIALSEDUCATIONAL CREDENTIALS
Qualification Institution Year
Master of Science (Microbiology) JRNRV University, Udaipur, Rajasthan 2007
Diploma in pharmacy OSBP Orissa 2000
Bachelor of Science Bot.(H) Utkal University, Bhubaneswar 1995
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9. PERSONNEL DETAILSPERSONNEL DETAILS
Date of Birth:Date of Birth: 07th
August 1975
Marital Status:Marital Status: Married
Date:
Place: Manoj Kumar Parida
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10. PERSONNEL DETAILSPERSONNEL DETAILS
Date of Birth:Date of Birth: 07th
August 1975
Marital Status:Marital Status: Married
Date:
Place: Manoj Kumar Parida
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