Vivek Sharma

• Heading a team of 40 members; spearheading Quality Control-Microbiology, and Sterility Assurance of Department, implementing framework of quality standards and managing smooth implementation
• Participate and CFT member for Facility Qualification, Equipment Qualification and Aseptic Media fills
• Budgeting for Quality control department and interactions with vendors &for procurement
• Review of Quality control – Microbiology documents and other relevant documents from cross functional teams
• Internal/ External Audits
• Quality Management System
• Participation in vendor audits and preparation of audit reports
• Initiatives in Harmonization of Microbiological activities
• Performing Risk Assessment studies
• To access gap in regulatory requirement and industrial bench marked aseptic practices
• Failure investigations
• Responsible for overall management of microbiology lab, sterile operations and sterility assurance
• To ensure that activities are executed in compliance with sterility assurance and as per predefined criteria
• To ensure the training of microbiologist and persons involved in sterile operations completed
• To ensure received samples are analysed as per approved procedure and results are communicated in timely planner
• To investigate OOS and deviation as per the standard procedure and root cause is identified and appropriate CAPA has been initiated and executed
• To ensure that activities properly distributed and completed as per predefine timeline with state of compliance
• To ensure the microbiology related equipment’s are maintained in qualified, calibrated and validated state throughout life cycle
• To check and review the results of documents protocols, SOP, Specifications standard test procedure analytical datasheets
• Procure consumables as required for day-to-day activity and compliance to the corporate and In-house SOPs
• To ensure Sample, culture and reference standards are maintained and stored as per the procedure
• To ensure the microbiological monitoring plans for water system and environment, personnel are executed appropriately and trends of data obtained, prepared reviewed and approved appropriately
• Ensuring compliance and audit readiness for external inspections / audits from regulatory / certifying agencies
• Taking adequate measures to ensure compliance with quality standards; implementing quality assurance methods to ensure defect-free products; attending complaints and developing corrective & preventive action plans
• Delivering training to microbiologist and persons involved in sterile operations
• Reviewing operational practices & documents for technology transfer, identifying areas of obstruction / quality failures and advising on system & process changes for qualitative improvement
• Facilitating quality audits of vendors, contract manufacturing sites & third-party sites
• Steering the implementation of (USFDA & MHRA) and managing stability studies as per the regulatory guideline or customer supplied protocol
• Preparation of all quality documents including VMP, Layout Drawings, Equipment Qualification Reports, Internal Audit Reports, Management Review Meeting Reports, Investigation Reports for market complaint, APQR, Deviation Report, Change Control Requests & Audit Compliance Reports
• Ascertaining complete in-process quality control and continuous improvement in process capabilities
• Creating and sustaining a dynamic environment that fosters development opportunities and motivates high performance amongst team members
• Involved in new Isolator injectable line and new water system qualification (Zydus pharmaceutical)

• Subject Matter expert (SME) Microbiology and sterile operation related activities at Wockhardt ltd
• Responsible for Microbiology related issues at 11 Sites (Microbiology Departments)
• Part of remediation team for regulatory requirements (USFDA & MHRA)
• Harmonization of Microbiological test procedures and other media fill related SOPs to facilitate the sites
• Performing the site audits related to production and microbiology related procedures as per regulatory requirement
• Performing Vendor Audits for API packing material
• Ensuring compliance against the Global Quality standards and regional quality assurance procedure and with respect to regulatory audit observation
• Review of investigation for root cause assessment, impact assessment and appropriate corrective and preventive action, if any
• Organize and participate in self-audit with role assigned as per the standard operating procedure and as per regulatory requirements
• Identify continuous improvement to improve compliance, process clarity and operational efficiency
• Review of standard Operating Procedure as a part of compliance to regulatory guidelines
• Audit Preparation for department Quality Assurance, Microbiology, Molecular Biology and Quality Control Departments
• Prepare Global CAPA for site implementation
• Training to different site for new procedures (SOP)
• Vendor Audit performed in abroad (Xang dong Pharmaceutical China)
• Involved in project Dubai, new site designing, Procurement, Commissioning Establishment & Qualification
• Involved in contract manufacturing (JHS Canada) for microbiology related issues
• Actively participated in Compliance Audit for different site
• Actively participated /interacted with Regulatory inspectors (USFDA & MHRA)
• Regulatory Compliance report preparation for regulatory departments (MHRA & USFDA)
• Recently faced USFDA inspection with zero observation from microbiology and sterility assurance

• Lead roles performed for QA and IPQA activities for Sterile Dry Powder Injectable (Ranbaxy Pharmaceuticals)
• Involved in investigation deviation, change control, Market complaint
• To check the Environment conditions as per the requirement (temp/RH) aseptic processing area
• To check and ensure the proper use of input materials before usage during routine manufacturing
• To check and ensure the proper segregation of the materials as per the status
• To give the Line clearance for batch to be manufactured at production
• To carry out the In-process checking at different stages of manufacturing and operations
• To review the batch record up to the relevant stage and ensuring the yield is within the standard yield mentioned
• To sample the semi finish and finish products as per the batch record and also as per the process validation protocols
• To collect the finished product control samples as per the requirement
• To collect and send the stability samples as per the requirement
• To participated in Aseptic Process simulation (Media fill)
• Leads Validation, IPQA, Audit, QMS and Compliance and documentation vertical in QA function
• Review and approval of master validation plan, drawings, layouts, URS, SAT, IQ, OQ, PQ, etc
• Responsible for Team Development and engagement
• Responsible for defining, implementing, managing and controlling all quality assurance and control systems in order to ensure quality of the product in compliance with established procedures and regulatory requirements
• Coordinate with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations
• Ensure that adequate controls on starting materials, intermediate products, and bulk products, finished products and other in-process controls, calibrations, and validations are carried out
• Ensure product release according to established procedures and after certified by authorized person
• Work across all cross functions to ensure that the Company maintains a state of readiness for inspection by regulatory authorities
• Conduct regular training programs
• Tracking, reporting of quality performance indicators (KPIs) that measure the quality and compliance on a routine basis and identified risks related to quality and compliance
• To ascertain Quality of recalled product and performing in depth evaluation for reasons for recall
• Ensure periodical verification of quality system by way of internal audits and handling of regulatory inspections and customer audits
• Provide Quality inputs for facilities during design/project phase
• Contributing to team effort by accomplishing results as needed
• To ensure compliance of quality documents and regulatory requirements
• Vendor qualifications
• Manage and evaluate (trending) product complaints, deviations, Corrective Actions and Preventative Actions
• Providing support to manufacturing activities as per Quality Management System (QMS) and GMP guidelines
• Directing quality control microbiology and Sterility Assurance activities
• Interaction with production, Regulatory and other CFT department for better functioning of Quality Control-Microbiology and Sterility Assurance
• Leading a team of quality professionals, including supervision of the employee performance management; including hiring, development &planning
• To develop skills and capabilities of people and to enable the organization to be flexible/adapt to the dynamic business conditions

Method validation of microbial limit test. Preparation of method validation protocols and reporting.

Performing the sterility test, bulk sterility (open and closed system) and sterility method validation for new products

Media preparation and its maintenance.

Anti-biotic assay by cup plate & Turbidimetric Method

Validation of Incubators, Autoclave and Dry heat sterilizer.

Perform IQ, PQ and OP for Sterility Closed System and validate the product.

Preparation of trend charts for water analysis, environment monitoring and for raw material analysis

Handling of Master cultures.

Preparation of cultures and culture dilutions. Calculation sheet preparation for all microbiological analysis.

Involved in all Aseptic Process Simulation activities

Disinfectants Qualification study

Bacterial Endotoxin test for water, raw material, and finished products and tunnel validation.

Antibiotic assay

📷 Cleaning validation by TOC and SSM analyzer.

Preparation of Standard Test Procedure, General Test Procedure and Good Documentation Practices

Knowledge of CGMP and GMP

📷 Environment monitoring in different production areas (A, B, C, D) and microbiology laboratory as well. (Entire plant)

Performed Area qualification

Performing the water analysis in the laboratory on day-to-day basis and water plant validation with respect to microbiology analysis.

Performing the Microbial limit test for various raw materials, tablets, capsules and oral solution as well as bio load of various samples.

Media preparation and its maintenance.

tors, Autoclave and Dry heat sterilizer.

Handling of Master cultures.

Preparation of cultures and culture dilutions. Calculation sheet preparation for all microbiological analysis.

Microbial identification