Job Objective

To work for an organization, where I can prove my worth, fulfilling the responsibilities given to me and to be a challenging person in each and every field of the life, having pleasure and comfort in working with team as well as an individual and continuously updating & upgrading my knowledge base and working hard & smart; with my maximum potential; to achieve organizational goals and self-satisfaction.

Profile Summary

ØSuccessfully participated and faced Domestic and Regulated audits (like - ROW Market ( Uganda/Nigeria / Ghana/ ZAZIBONA/ Ukrain/ Tanzania / Phillipines/ Srilanka /Gulf /Sudan/ EU GMP / 3rd part customer audits- Sun Pharma, Pfizer, Medrich, Aristo, Alkem/ GLP etc.,)

ØExperienced in cGMP and regulatory environment; working experience of OSD, Oral Liquid, Injectables (SVP, LVP & PFS) and Lyophilized products.

Ø Skilled in review & approval of:

oQMS Documents as Change Control, Deviations, Incidents Corrective & Preventive Action (CAPA), Out of Specification (OOS), Out of Trend (OOT).

oValidations & Qualification of equipment’s like- Injectable Manufactuirng Lines:- Filling Line, Vial Washing machine, Depyrogenation Tunnel, Autoclave (Steam Sterilization), Autoclave cum Bung Processor, Terminal Sterilzer, External Vial Washing Machine, Automatic / Semi-automatic Inspection Line.

oOSD Machine Qualification

oUtilities (Area Qualification-HVAC, LAF) and Water System

ØProven record of establishing processes & SOPs, streamlining workflow and creating healthy environment to enhance productivity & quality.

ØA forward-thinking person with strong communication, analytical & organizational skills; well organized with a record that demonstrates self- motivation & creativity to achieve corporate quality goals

Key Impact Areas

·Quality Assurance

·Corporate Policies & Compliance Program

·Training & Presentation

·Review & Approval of QMS Notifications

·Audit & Compliance / Remediation

·Risk Assessment and Root Cause Investigation

·Vendor Qualification, Equipment / Area Qualification Validation

·Quality Audits & Inspection

·Project Management/ Reporting & Documentation

2006

B.Pharma from Uttar Pradesh Technical University - (M.I.E.T).

2001

12th from D.P.S, Vidyuth Nagar-N.T.P.C.

1999

10th from D.P.S, Vidyuth Nagar-N.T.P.C.

June’06-July’07 Aug’07-April’08 May’08-Feb’11 March’11-June’18 Oct’18-Jun-2022

Jul-2022 till date

Since July-2022 : Inject Care Parental Pvt Ltd as 'Manager' in Quality Assurance

ØReview & approval of QMS Documents as Change Control, Deviations, Incidents Corrective & Preventive Action (CAPA), Out of Specification (OOS), Out of Trend (OOT)&Laboratory Investigation report (LIR)

ØParticipating in remediation & certification program on Systems & Processes like Documentation, Training, Preventive Maintenance, Technology Transfer, Complaint, Qualification of Manufacturing Equipment / Utilities, Self-inspections, Incident Management, Material Control, Production & Process Control, Warehouse & Distribution Control and Supplier Management & Qualification.

Ø Steering Vendor Development, Selection & Vendor Qualification; managing Market Complaints, and Product Recall

/ Return Procedure.

ØPerforming quality risk management (QRM) in several process/areas and detection of risk priority numbers and implementation of CAPA on potential failure.

Ø Managing and conducting Internal audits / self-inspection; assuring compliance to cGMP & GLP at manufacturing site

Ø Working with National and international consultancies for Site audit Regulatory audit readiness / Gap Implementations.

Ø All time site readiness for Regulatory audits.

Ø Identifying of personnel for Self Inspection / Vendor audits / Trainers and qualifying for the same as per the procedures.

Ø Heading preliminary evaluation and firm up of vendors w.r.t. organizational requirements and managing Vendor

ØAudit Agenda and conducting Vendor Audits as a part of Vendor Management.

ØPerforming Internal, Vendor & Contract Manufacturer Audits and working on product manufacturing & test license applications; attending Management Review Meetings (MRM)

ØDirecting Incidents/Deviation, CAPA, Risk Assessments, Change Control, Market Complaints and Product Recalls Leading Critical Investigations and SME while Investigations

ØIdentifying of all critical activities w.r.t. open and closed operations to assess the Process and Facility Risks Conducting and participating in Brain Storming sessions for the compliance of Risky Operations and flow Implementing and managing qualification of automation systems in place of Manual operations

ØExecuting and ensuring Aseptic Process Simulation as per current regulatory requirements Planning of qualifications and validations as per Project Plan

ØResponsible for preparation / Review / Approval of Validation protocols and reports like URS, FAT, SAT, IQ, OQ, IOQ, PQ, PV, CV and Performance verification of various equipments like Injectable Manufactuirng Lines, Filling Line, Vial Washing machine, Depyrogenation Tunnel, Autoclave (Steam Sterilization), Autoclave cum Bung Processor, Terminal Sterilzer, External Vial Washing Machine, Automatic / Semi-automatic Inspection Line, Packing Line, Utilities (Area Qualification-HVAC, LAF) and Water System.

ØExecution and Approval of DQ, FAT, IQ, OQ, IOQ & PQ Protocols and Reports

ØPreparation, review and execution of process Validation protocols and Cleaning validation protocols as required by the Operations.

1) Oct ’18-June 2022 : Scott Edil Pharmacia Ltd, Baddi as 'Sr. Manger' in Quality Assurance

ØReview & approval of QMS Documents as Change Control, Deviations, Incidents Corrective & Preventive Action (CAPA), Out of Specification (OOS), Out of Trend (OOT)&Laboratory Investigation report (LIR)

Ø Participating in remediation & certification program on Systems & Processes like Documentation, Training, Preventive Maintenance, Technology Transfer, Complaint, Qualification of Manufacturing Equipment / Utilities, Self-inspections, Incident Management, Material Control, Production & Process Control, Warehouse & Distribution Control and Supplier Management & Qualification.

Ø Steering Vendor Development, Selection & Vendor Qualification; managing Market Complaints, and Product Recall

/ Return Procedure.

ØPerforming quality risk management (QRM) in several process/areas and detection of risk priority numbers and implementation of CAPA on potential failure.

ØManaging and conducting Internal audits / self-inspection; assuring compliance to cGMP & GLP at manufacturing site

ØWorking with National and international consultancies for Site audit Regulatory audit readiness / Gap Implementations.

ØAll time site readiness for Regulatory audits.

ØIdentifying of personnel for Self Inspection / Vendor audits / Trainers and qualifying for the same as per the procedures.

ØHeading preliminary evaluation and firm up of vendors w.r.t. organizational requirements and managing VendorAudit Agenda and conducting Vendor Audits as a part of Vendor Management.

ØPerforming Internal, Vendor & Contract Manufacturer Audits and working on product manufacturing & test license applications; attending Management Review Meetings (MRM)

ØDirecting Incidents/Deviation, CAPA, Risk Assessments, Change Control, Market Complaints and Product Recalls

ØLeading Critical Investigations and SME while Investigations

ØIdentifying of all critical activities w.r.t. open and closed operations to assess the Process and Facility Risks

ØConducting and participating in Brain Storming sessions for the compliance of Risky Operations and flow

ØImplementing and managing qualification of automation systems in place of Manual operations

ØExecuting and ensuring Aseptic Process Simulation as per current regulatory requirements

ØPlanning of qualifications and validations as per Project Plan

ØResponsible for preparation / Review / Approval of Validation protocols and reports like URS, FAT, SAT, IQ, OQ, IOQ, PQ, PV, CV and Performance verification of various equipments like Injectable Manufactuirng Lines, Filling Line, Vial Washing machine, Depyrogenation Tunnel, Autoclave (Steam Sterilization), Autoclave cum Bung Processor, Terminal Sterilzer, External Vial Washing Machine, Automatic / Semi-automatic Inspection Line, Packing Line, Utilities (Area Qualification-HVAC, LAF) and Water System.

ØExecution and Approval of DQ, FAT, IQ, OQ, IOQ & PQ Protocols and Reports

ØPreparation, review and execution of process Validation protocols and Cleaning validation protocols as required by the Operations.

2)Worked as Senior Manager - Quality Assurance Department, Venus Remedies, Ltd, Baddi, Himachal Pradesh, India, since March 2011 Till May-2018.

Venus Remedies Ltd. deals in parental product categories as Cephalosporin Injection, Carbapenem Injection, Anticancer Injection (Liquid and Lyophilized), Prefilled Syringe, General Antibiotic Injections,

ØInvolve in Internal Audit and External Audit.

ØExecution of Vendor Audit.

ØHandling for market Complaint.

ØPreparation and review of APR.

ØLook after the Deviations and it compliance.

ØImplementation of CAPA.

ØImplement quality-training programs for key quality & manufacturing personnel and supply chain.

ØTechnical support to manufacturing site.

ØCo-ordination with R&D, Plant and regulatory dept.

ØAlso In process check and quality system evaluation when visited to third party and P2P products.

ØPreparation and execution of Qualification and Validation Protocol like Injectable Manufacturing Lines, Filling Line, Vial Washing machine, Depyrogenation Tunnel, Autoclave (Steam Sterilization), Utilities (Area Qualification-HVAC, LAF) and Water System.

3)Worked as CQA Management staff with Cipla, Ltd., Since May 2008 until Feb- 2011. Key Responsibilities Handled

ØProduction planning with respective of Quality.

ØDeveloping an integrated management system for meeting the production orders.

ØTaking care of inter dependent issues to achieve good Quality for Product.

ØPlanning of weekly monthly and quarterly shortages as per the trend analysis of orders and placing the shortages indents to purchase.

ØInventory control measures to meet market demand.

ØExeution of production as per requirement from Planning and Export department according to cGMP and Cipla Specification.

ØRoutine Audit of Existing location, new location etc.

ØFollow up for CAPA from the location for Non compliance

ØPreparations of Report & Deviations.

ØIncoming Materials Inspection, Incoming and In-House.

ØImplementing inspection for incoming material and setting the trend analysis.

ØWorking in close coordination with vendors by providing technical guidance and deployment of quality plan for delivering raw materials.

ØPlanning and conducting process audits at vendor’s end, vendor up-gradation and rejection control through various tools.

ØPeriodic evaluation of vendor performance in terms of quality of Packing Material, and seeking corrective measures in improving the quality of raw materials.

ØProduction Planning, Material indents, Inventory Management, Document review of Stores

ØShortages and minimum inventory level analysis based on minimum lead-time.

ØPerformance qualification of the Packing Materials, Pre-dispatch approval of the PM.

ØCo-ordinate closely with different departments to meet the plan.

Timely completion and meet the demands of Product by giving timely and effective technical and commercial support.

Execution of production as per requirement from Planning and Export department according to cGMP and Cipla Specification.

ØRoutine Audit of Existing location, new location.

ØControlling of all the QA-QC activities, like IPQC, RM/PM analysis, Stability study review, change control, deviation, Process validation and online Documentation.

ØTechnology Transfer from location to location or from Cipla unit to location in co-ordination with various departments.

ØLooking after the Dry Powder Injection Product& Liquid Injection Batches & Eye Drops Batches.

4)Worked as QA officer with M/S Nectar Life Science Ltd., in Dry Powder Injection section since August 2007 until April 2008.

Key Responsibilities Handled

ØTo prepare production BMR for cephalosporin.

ØTo look after IPQA activity of cephalosporin section.

ØPreparation of SOP

ØPreparation of training documents for the workers.

ØMaintenance area records as per current GMP Requirement.

ØPreparation follow up of preventive maintenance schedule for all equipment and system.

ØMaintain effective communication among departmental as well as interdepartmental level.

ØTo show the departmental site and available facilities to external auditor & visitor.

ØHaving knowledge of operating Macofar machine (Tunnel, Filing machine, Sealing machine).

5)Worked as QA officer with M/S Scott-Edil. Pharmacia Ltd (WHO Certified Company) in injectable department (Dry powder injection & Liquid injection) since June 2006 until July 2007.

Key Responsibilities Handled

Looking after the Shop Floor Production Activities in coordination with Validation Department.

MS-Office, Browsing.

Type Writing (English Lower)

Superior and Quick learner of Pharma Software’s at Site level

Name: Meraj Hassan. Father’s Name: Mr. M. Hasan. Date of Birth: July 01, 1984. Marital Status: Married.

Gender: Male. Language Known: English/Hindi. Nationality: Indian.

Address for Correspondence: Shiv Shakti colony, Nalaghar Road, Pinjor, Himachal Pradesh, India.

I assure you that the above-furnished information is true in every aspect and area on my behalf. Place: Vapi (Meraj Hasan)

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