Viswanatha Narasimham Vishnuvarjala.

Cell No: +1-980-***-****

ac7qpp@r.postjobfree.com

ac7qpp@r.postjobfree.com

Resume

Senior Pharma professional with over 18 years’ experience in all tenets of Production, Planning and Execution, Supply Chain Management and SAP implementation. Have proven track record of creating robust systems and processes from scratch that have led to high productivity and competitive work environment. Have also led various strategic organization-wide initiatives.

Legally allowed to work in the US for any organization.

Professional Experience:

1. Organization : Mylan Laboratories Limited, Bangalore.

Duration : Feb. 2015 to May 2018.

Role : Senior Group Leader – Production

Responsibility:- Managing a workforce of about 125 employees with 13 Production Executives.

Specific responsibilities and accountabilities include:

Responsible for Production, Planning and Execution of Leak Testing, X-ray inspection, Visual inspection (Manual and automatic) and Packing of injectables.

Preparation of monthly and annual reports.

Process Improvements in the Production Department.

Preparation of Controlled documents like URS, QRM, SOPs.

Reviewing of SOPs, validation protocols and others quality documents.

Documentation as per cGMP Guidelines and GDP.

Successful implementation of Serialization and Aggregation project as a project lead along with the global team.

Successful implementation of automatic inspection of liquid injectables as a project lead with an implementation partner based in Germany.

Worked closely with the global team and different vendors on the implementation of fully automatic vial packing line.

Responsible for art work management (AWMS).

Well versed with Incident, Investigation, Market complaints and Change management on Trackwise.

Well versed with documentation on Documentum and CARA the SOP system.

Well versed with preparation of URS, Rationale, Justification papers etc.

Training of all the operators and supervisors on current practices, procedures and documentation as per cGMP and GDP.

Qualified auditor to conduct internal audits as per cGMP.

2. Organization : Himalaya Drugs Company, Bangalore

Duration : August 2004 to February 2015.

Role : Manager – Production

Responsibility: - Managed a workforce of about 300 employees with 12 Production Executives.

Specific responsibilities and accountabilities included:

Was responsible for Production, Planning and Execution of Tablets, Capsules, Topical packaging and Ophthalmic preparations.

Worked with all departmental heads on a daily basis in terms of Production Planning and Inventory control. This also involves interactions with Procurement and Quality Control Department.

Co-ordination with International Marketing Department and different HUBs on timely FG deliveries.

BMR review of all the lines.

Responsible for Material and Manpower Planning & Management.

Preparation of monthly and annual reports like Export overview report, Value and volume report, productivity report, performance reports on delivery against plan etc.,

Process Improvements in the Production Department.

Preparation of Controlled documents like QSP, MMR, RM and PM Specifications, Validation protocols, SOP and OCP.

Documentation as per ISO, GMP Guidelines like Log books for each processes and equipment, BMR’s, Training manuals etc.,

Coordinator for ISO 14001-2004 (environmental management system) and safety aspects.

Was chosen to be one of the core members of SAP implementation team. As a core member, I was responsible for;

oPreparation of master data required for training and preparation of procedural manual for carrying out testing by the Loan License and HDC end users.

oTrained almost 42 contract manufacturing units and HDC end users in as many as 15 teams. Continued as SAP coordinator for Production planning module for all the contract manufacturing plants and in-house production plant in addition to the production activities.

oConducted test after the training to assess the trainees.

oEnsured all the LLs are trained in the quality server before GOLIVE.

oWon the 2nd prize in a test conducted by implementation Partners (IBM) on SAP.

3. Organization : Healthline Pvt. Ltd. Bangalore.

Duration : April 2003 to Aug 2004

Role : Asst. Manager – Production

Responsibility:

Was responsible for Small Volume Parenteral Product and Oral Liquids Production.

Experience in validating equipment like Mixers, New machineries at New facility and process validations.

Worked in QAD as process controller of LVP, SVP & ORAL LIQUIDS

Was also responsible for regulatory activities (Drug Control Office) like Applying for No-conviction certificate, Free sale certificate, Performance certificate, QP Proforma, Renewal of GMP certificate etc.

Audited many departments like Production, Stores, Maintenance, Quality Control, Purchase and R&D as an Internal Quality Auditor based on ISO.

4. Organization : Provimi (erstwhile Vetcare). Bangalore.

Duration : March 2000 -April 2003

Role : Production Officer

Was responsible for stores activities and production for one of the production units.

Was handling the manpower planning and ensuring the production targets were met as per the timelines.

Experience as a safety officer.

Key Accomplishments:

Successful implementation of SAP in Production Planning Module. Rated the best core committee member by the SAP implementation partners (IBM) at Himalaya Drugs Company.

Ensured that the production facility at Himalaya Drugs Company is approved by the Ministry of Health by Iran Government.

US FDA audit was successfully completed twice without any observation from the inspection and packing department. Similarly, TGA audit was also concluded without any observations at Mylan Laboratories Limited.

Successful implementation of Serialization and Aggregation project at Mylan Laboratories Limited.

Successful implementation of automatic visual inspection machine at Mylan Laboratories Limited.

Was the recipient of BEST PERFORMANCE AWARD for the year 2001-2002 at Vetcare.

Trainings:

01)Have attended various quality related trainings on ISO, cGMP, TQM and SAP.

02)Qualified auditor training for ISO 14001 (Environmental Management System)

03)Undergone various Leadership Trainings

04)Qualified GMP auditor

ACADEMIC DETAILS

Graduate in Pharmacy (B Pharma), Bangalore University 1995 to 1999, Bangalore - India– Secured First Class

Diploma in GMP (Good Manufacturing Practice) Jan.2010 to Oct.2010- Secured First Class

KEY SKILLS

SAP, ERP, Trackwise, Change management, Deviation management, Market complaint handling, Serialization and aggregation, USFDA, TGA, cGMP, Production planning and execution, Manpower management and training, Preparing and reviewing SOPs, Internal and External audits.

PERSONAL DETAILS

Contact Address : 11120. Maplehurst drive.

Charlotte. NC. 28277

EAD status : Approved. Valid from: 09/20/2018 to 09/19/2020.

Legally eligible to work for any organization in the U.S.

Category: A18 (Spouse of an intracompany transferee L1 visa holder)

(Viswanatha N Vishnuvarjala)

Place: Charlotte. NC.28277

Date:

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