Core Competencies

Soft Skills

Quality Assurance & Control

Process Enhancement/Improvement

Business & Operational Excellence

Strategy Planning & Execution

Budgetary & Cost Control

Audits & Inspections

Safety Standards

Laboratory Operations

Team Management & Leadership

Documentation & Reporting

cGMP & GDP

Training & Development

Communicator

Collaborator

Strategic

Decision Maker

Leader

Motivator

Analytical

Team Builder

Career Timeline

Profile Summary

Strategic Leader offering experience streamlining/overcoming complex business challenges, participating in high level operational initiatives including turnaround management and reorganization while delivering results in growth, revenue and operational performance

Expertise in Quality Management System including audits and recommending & implementing corrective actions while ensuring in-process quality control and continuous improvement in process capabilities

Proven success in identifying improvement areas and implementing adequate measures to attain corporate goals/targets

Competent in investigating of Product failure, OOS, OOT, Market complaints, Deviations and evaluation of Impact/Risk Assessment to identify the appropriate root causes and CAPAs

Proficient in coordinating with manufacturing, purchase, regulatory and R&D for smooth, effective & timely execution of exhibit & commercial batches and new product launches

Extensive exposure of developing, implementing and maintaining quality systems procedures in compliance with quality standards Experienced in training the employees on various guidelines such as 21 CFR part 210, 211, 11; ICH Guidelines; EU ANNEXURE 1 & 11 and Industry Sterile Drug Products, Produced by Aseptic Processing cGMP

Distinguished capacities & expertise in conducting audit & compliance of pharmaceutical formulation in several dosage forms such as Tablets, capsules, Liquids, Ointments and Dry Syrup

Successfully analyzed quality assurance operations and ensured that products are manufactured, tested released in a way that takes account of the requirements of cGMP and other regulatory requirements Education & Credentials

B.Pharma from B.R. Nahata College of

Pharmacy, MP in 2009

Certification

Diploma in MS Office

Technical Skills

MS Excel, MS Word, MS PowerPoint

Pharmasuite

Marg

SAP System

Single Layer

Single/Double Rotary Compression M/c, Bilayer

D/B Tooling M/c- SIP, Karnavati, Cadmach,

Fette, & Inlay IMA Kilian Compression M/c,

Coating M/c Auto Coater, Wurster Coater (Glatt)

both top & bottom

External Audits Executed

Local FDA: (Cipla-2009)

WHO: (Cipla-2010)

MHRA: (Wockhardt-2011&13)

Perrigo: (Wockhardt-2011)

USFDA: (Wockhardt-2011&13)

WHO, USFDA: (Ind Swift Limited 2014&16)

WHO, ZAMBIA (MOH)

YEMEN (MOH): Lark Laboratories India Ltd.

(2017-2018)

Anurag S Tiwari (FDA Approved Chemist)

An enthusiastic & high energy-driven professional, with an experience of 11 years and targeting strategic level assignments in Quality Assurance & Control in an organization of repute in Pharmaceutical industry

Phone: +91-860******* E-Mail: ade56l@r.postjobfree.com May’ 09 to

Oct’ 10

Cipla

Pharmaceuticals

Ltd.

Oct’ 10 to

Apr’ 14

Wockhardt

Pharmaceuticals

Ltd.

Jul’ 16 to

Jan’ 17

Pfizer India

Ltd.

Apr’ 14 to

Jul’ 16

II nd Swift

Jan’ 17 to

Oct’ 18

Lark

Laboratories

India Ltd.

Oct’ 18 to

Present

Africure

Pharmaceuticals

Ltd.

Work Experience

Oct’ 18 to Present

Africure Pharmaceuticals Ltd. as Corporate QA Head (Solids, Liquids, Capsules, Dry Powder, Sachets) Jan’ 17 to Oct’ 18

Lark Laboratories India Ltd. as Head QA (Solids, Liquids, Capsules, Ointment, Creams, Gels) Apr’ 14 to Jul’ 16

II nd Swift as Assistant Manager – QA (QMS & Lab) (Solids, Liquids, Capsules) Jul’ 16 to Jan’ 17

Pfizer India Ltd. as Senior Executive (Training & Compliance) Oct’ 10 to Apr’ 14

Wockhardt Pharmaceuticals Ltd. as Senior Officer (QA) (Solids, Liquids, Capsules, Dry Powder, Sachets, SVP) May’ 09 to Oct’ 10

Cipla Pharmaceuticals Ltd. as Trainee Officer (Solids, Capsules, Dry Powder, Sachets) Key Result Areas:

Monitoring overall functioning of Quality Assurance Process; identifying improvement areas and implementing adequate measures to attain organizational goals/targets and improving the safety culture Managing the entire gamut of QA/QC Operations including resolving the problems and updating the same periodically with the actions/RCA to be undertaken throughout

Coordinating cross-functionally with Manufacturing, Procurement, RA, R&D, PDL, ADL, PQA, CQA & so on to provide timely support to Supply Chain while ensuring quality & compliance

Conducting periodic gap analysis and implementing measures to improve laboratory compliance Reviewing & validating specification, STP, TDS, Protocols, Analyst Qualification And Analytical Method Validation Documents and ensuring compliance

Identifying & resolving laboratory incidents, OOS, OOT and deviations in a timely manner by implementing appropriate CAPAs Driving continuous improvement of overall cGMP compliance in line with the cGMP /GDP & regulatory expectations Establishing processes & SOPs leveraging best practices to ensure process improvements, eliminate bottlenecks, realize operational efficiencies, control cost & reduce cycle time

Leading validation, planning and manpower allocation; collaborating with external agencies & customer service department, providing training to Associates/Operators, and identifying the needs for the same Spearheading source inspection activities, monitoring/revising quality documentation, maintaining compliance with standards pertaining to industry and reporting internal audit information Conceptualizing & implementing effective techniques in bringing efficiency in operations for improving quality standards and achieving best possible cost savings

Detecting the value added & non-value added activities by value stream mapping & elimination of non-essential non-value added activities for enhancing the operational efficiency & throughput time Ensuring compliance of various quality measures by maintenance of appropriate requisite documentation Liaising with the EHS Manager and administering EHS related activities at sites, disposal of hazardous wastes & safety issues Building risk management approach in QMS policies, strategies, procedures and practices; devising an appropriate mechanism to detect risk to products and taking expeditious for its containment Preparing appropriate trend analysis and annual product reviews to assess the performance of QA and update the system and control where necessary

Highlights:

Actively participated in preparation for regulatory audits like US-FDA, MHRA & TGA Successfully audited 300 Business partners like API, Excipients, Primary, Secondary and Tertiary Packaging Materials Effectively trained & mentored over 3000 people for cGMP and GDP Drove Continuous Improvement including equipment, process and system improvement projects to achieve operational excellence Improved productivity through process KPIs & developing SOPs by effectively adopting simple Risk based approach and implementing CAPA

Ascertained the daily execution report and progress to make sure that team works within the set schedule as well as project progress, identified issues and effort/schedule deviations

Successfully implemented operational excellence plans, thereby leading to an increase in efficiency (process and human resource) for process excellence

Personal Details

Date of Birth: 25th March 1986

Languages Known: Hindi, English, Marathi & Gujarati Address: Behind 2nd Electronic Transformer, Umari Colony, District Satna- 485001, MP

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