Resume

Yogesh Darji

Phone No: 609-***-****, Mob:609-***-****

** ******* **, ********, ** 18914.

Email: ac0gal@r.postjobfree.com

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Summary

Experience in cGMP manufacturing and technical knowledge in validation of pharmaceutical processes/systems/equipments.

Expert in project Management and organizational skills, including ability to follow assignments through to completion of investigation.

Strong understanding of GMPs and GLPs and have previous experience working within highly regulated pharmaceutical facilities.

Strong technical writing and problem solving skills.

Responsible for investigating events/non-conformances encountered in Drug Substance and Drug Product manufacturing operations.

Lead investigation efforts and make recommendations towards mitigation of event by identifying or recommending appropriate corrective and preventive actions (CAPA).

Rich of Experience interacting with regulatory agencies and health authority inspections.

ACADEMIC BACKGROUND

Institution

Period

Major Degree

Sardar Patel University

1990-1995

Bachelor of Pharmacy

Gujarat Technological University

2012-2014

Master of pharmacy

PROFESSIONAL EXPERIENCE

More than 7 years of validation experience in the pharmaceutical environment

March-2002 to Present: Regulatory Department

Worked as FDA Inspector in state Food and Drugs Control Administration (FDA), Gujarat State –India (Exp.).

March-2001 to March-2002: Aristo Laboratories Ltd., DAMAN-India (cGMP compliant & WHO Approved).

Work as production Executive. Well acquainted with manufacturing unit operations planning, execution and achieving set goals/targets with team work

The firm was engaged in manufacturing of Liquid and Dry Powder Injection

Responsible for timely productions and maintaining BPRS according to WHO, TGA & USFDA other regulatory requirements.

AUG-1998 to MAR-2001: Cadila Healthcare Ltd (Zydus Cadila), India (WHO, TGA & USFDA approvals).

Worked as Production officer well acquainted with manufacturing unit operations planning, execution and achieving set goals/targets with team work.

Because of previous work exposure and continual learning efforts has Developed Excellent skills in various product manufacturing in drug formulation categories of Injectable (small volume and large volume), Soft gelatin Capsule and Hard Gelatin Capsules.

As a regulatory requirement, been approved as Technical person in Injectable manufacturing section by FDA- (Government of Gujarat-State –INDIA).

FEB-1997 to AUG-1998Intas Pharmaceuticals Ltd. Gujarat, India (WHO, TGA approved)

Worked as a production officer in manufacturing of PARENTERAL drug formulation products.

Active participation in Daily drug formulation manufacturing activity which included manufacturing, filling and packing of drug formulations in the category of small volume Injectable.

DEC-1995 to FEB-1997Shree Krishna Keshav Laboratories ltd, Gujarat, India (cGMP compliant).

Worked as a Production Assistant.

Involvement in the production planning, Manufacturing, Labeling/packaging activities. Responsible for achieving set target as per planning and management of relevant operations.

Active participation in maintaining Quality and Safety requirements as per regulatory and cGMP norms.

Compliance of the queries and CAPA raised because Internal and External Audits.

Team member of Internal Audit Activity of the manufacturing of different production areas and warehouse.

Monitoring and controlling Shop floor activity like in process checking in Tables Capsules, Packing, Raw Material Stores, Packaging Material Store etc.

Review of complete documentation before Batch Release of product.

To plan and perform Process validation/revalidation, cleaning validation, Area qualification/requalification, calibration/recalibration and relevant activities for various products.

Organizing and reviewing training schedules. (Induction as well as on job)

Partner with functional areas and in a team environment to provide ‘on-the-spot’ input and guidance in responding to deviations

Ensure a constant state of inspection readiness ensuring that deviation and CAPA documents remain current.

Ensures that documentation are complete, accurate, and documented according to written procedures and cGMP.requirements.

Alerts of quality, compliance, supply and safety risks.

Completes required assigned training to permit execution of required tasks

Performs additional duties as specified by management.

Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment.

Some understanding of IQ, OQ, and PQ

Document all performed analysis as per cGMP, USFDA and 21CFR211.194 guidelines.

Follow cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices), 21CFR211.22, 21CFR211.28 and 21CFR211.170.

Follow the OSHA (Occupational Safety and Health Administration) and EPA (Environmental Protection Agency) safety regulations.

PERSONAL SKILLS :

Carried out Inspections of Drug formulation, API manufacturing and Testing facilities for compliance of regulatory requirements of law of land and c GMP, WHO- TRS21 CFR210.211, TGA, MHRA and USFDA- individually and with central licensing body, India, under the scope of regulatory service of state FDA(Gujarat).

The inspections were focused on the highest production standards through effective compliance of all quality parameters as per cGMP as well as current global requirements throughout products whole life cycle.

Having excellent team spirit, supportive to inspecting team members and possesses good communication skills.

Experience in various dosage forms such as tablets, capsules, Injectable (liquid & powder)

Excellent interpersonal, communication, managerial and organization skills.

Familiar with regulatory requirement of land of law as well as international guidelines and regulations.

Proficient with common computer operating on hardware and software including Microsoft Office.

Training:

10 days regulatory/professional training at renowned Institute of pharmacy education NIPER, at Chandigarh,

Training and workshop on medical device regulations.

Two days regulatory training under WHO capacity building project with support of CDSCO (A central drug licensing body of India) and Two days Trainings on USFDA regulations.

Have completed compliance wire on line training course, provided by UL Eduneering (USA) under a collaborative effort of department and institute.

Participated as a team member for state, in training and workshop on WHO..

A hands-on training on HPLC(waters) instrumentation software for better understanding and regulation.

Being in regulatory service since long the additional initiatives and responsibilities carried out also viz.

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