BALAMURUGAN.G Phone: 956-***-****

E-Mail: ac3gj7@r.postjobfree.com

Seeking assignments at a suitable position.

SYNOPSIS

Handling asManager QualityControl in one of the India’s biggest API manufacturing organisations with 2000 manpower in various level. Having oriented professional with over 15 years of experience in Bulk drugs.

Currentlyassociated with SUN PHARMACEUTICALS INDUSTRIES LTD,CHENNAI as Manager.

Responsible for Monitor & review the effective implementation of Quality Management Systems & compliance viz. batch release, product reviews, change controls, incidents, trending,document controls in the plant.

Take decision on medium & low risk areas in regards to quality systems, CAPA,market complaints, OOT, Investigate the batch & product failures, market complains and flag off to the supervisor for guidance and support, implement the action plan in consultation with the supervisor .

Guide & monitor the team in reviewing,facilitating & adhering to quality systems related with product stability & intimate regulatory authorities (internal & external) incase of failed studies on a pro-active basis.

Review the dossiers & ensure the batches manufactures are in compliance with the same and the licence & statutory requirements are met . Flag product stability issues / failures to the supervisor & seek guidance for appropriate action.

Ensure GMP & statutory compliance by facilitating internal (self-inspections) as well as external regulatory audits (WHO, US FDA, KFDA,MEXICAN FDA,MHRA etc.)

Guide & monitor the team in ensuring compliance for planned events such as revalidation as per validation master plans, calibration,preventive maintenance plans ; for events such as any changes in the area, equipment or process involved in the plantand also incase of introduction of new products or any other unplanned events in order to ensure the facility & processes are in validated state.

Identify, evaluate and implement continual improvement excercise to improve QA productivity as well as simplify systems & procedures

Comprehensive Review of documentation prior to product release .

Approve / reject quality Notifications such as, Incident, Change control, OOS, etc in a quality and timely manner, ensure investigations of failures / complaints and response to stakeholders.

In order to ensure Proper release of products for commercialization, no inadvertent release & compliance to the systems .

AREAS OF EXPERTISE

Setting up the labs Installation Validation(IQ,OQ&PQ), Preventive maintenance, Breakdown maintenance,Calibration,SOPs,Master Schedules, Audits Internal and External 21CFR Part 11 Compliance, Backup and Disaster management and Vendor Evaluation, safety implementation.

Pharmacopeial analytical method verifications.

Strong knowledge of cGMP/cGLP/GDP this knowledge laid down in CFR as well as by other regulatory agencies.

Troubleshooting of QC instruments&Key Instruments handled(HPLC – Waters-Empower,Agilent-Chemstation,Shimadzu-ClassVP,Prominence,LC Solution with PDA,UV,RI Detectors).

Gas Chromatography(GC)– Agilent,Perkin erlmer,Shimadzu

Gel Permiation Chromatography(GPC)– Waters

Ion Chromatography (IC)– Metrohm

LCMS(Waters-Quattro premier).

GCMS(Agilent)

FT-IR spectrophotometer [Perkin Elmer Spectrum two],

DSC[Waters Q20],

Polari meter[Rudolph- Autopol V]

Strong ability to understand, interpret and present scientific data independently.

Strong analytical skills to grasp problems (complexity, context etc), the scope of the solution and effort to solve.

Microbiology ( Environmental monitoring,Water analysis).

Quality Management Systems.

CORE COMPETENCIES

Monitoring adherence to quality systems, comply with quality standards & maintaining requisite documents.

Prepare and review controlled documents; Monitor distribution, revision, retrieval, archival and destruction of controlled documents; Support for DMF/ ANDA filing and regulatory queries; Prepare new documents as per cGMP requirement.

Participate and provide inputs in investigations related to OOS/ deviations/ customer complaints/ OOT/ incidences/ return goods/ recalls in collaboration with cross functional team.

Monitor the online compliance activities during manufacturing operations; Provide line clearances after satisfactory review BMR: Plan for in-process sampling as per production schedule.

Monitor the plant activity and prepare necessary documents with respect to change control action plans; Follow up on approved change control procedures to ensure execution is in line with action plan; Prepare validation documents and conduct first level review of the same; Monitor the execution of validation/ qualification processes at each stage of manufacturing.

Compile the vendor evaluation data/ documents; Maintenance of master data SAP related to vendor; Perform audits of shortlisted vendors as per schedule; Conduct first level review of the approved vendor list.

Conduct first level review of the relevant documents (batch production records, analytical raw data, packaging records, label records etc.) related to QA release.

Engage with employees; Direct and guide team on departmental issues; provide on-job training to team members.

Coordinate with instrument suppliers for renewal of Annual maintenance Contract and maintenance of spares.

Good handling & troubleshooting knowledge of various laboratory equipments

Identifying scope for implementation & monitoring of technological changes to enhance productivity.

Executing cost saving techniques / measures and modifications to achieve substantial reduction in Lab byTQM technique.Expenditures and work within the targeted budget.

ORGANISATIONAL DETAILS

S.No

Name of Organisation

Position Held

Working

Regulatorties Approved

From

To

6.

Sun Pharmaceuticals Industries Ltd, Chennai.

Manager

Nov-2016

Present

ISO 9001, TGA, USFDA,WHO

5.

Nuray Chemicals Pvt Ltd, Chennai.

Manager

Oct-2012

Nov-2016

USFDA,WHO

4.

Shasun Pharmaceuticals LTD, Cuddalore,Tamilnadu.

Senior Executive

(Assistant Manager)

Feb-2012

Oct-2012

ISO 9001, TGA, USFDA,WHO

3.

Aurobindo Pharma Ltd, Visakhapatnam.

Senior Executive

(E4 Level)

Apr-2008

Feb-2012

ISO 9001, TGA, USFDA,WHO

2.

Sri Krishna Pharmaceuticals Ltd,

Sri Krishna Drugs Ltd, Hyderabad

Executive

Mar-2007

Apr-2008

ISO 9001, TGA, USFDA,WHO

1.

Covalent Laboratories (P) Ltd, Hyderabad

Executive

Aug-2003

Mar-2007

ISO 9001:2000, 14001, 2004 WHO GMP

6.SUN PHARMA INDUSTRIES LTD. (Nov-2016 to Present)

MANAGER (QUALITY CONTROL)

The Company:Sun pharma is one of the big players in Bulk drugs and formulation having a standard like USFDA,MHRA,WHO,EU,KFDA,Mexican FDA and audited by all major International regulatory agencies.

The Accountability& Attainments

Monitoring adherence to quality systems, comply with quality standards & maintaining requisite documents.

Provide inputs in investigations related to OOS and Lab events.

Monitor the online compliance activities during manufacturing operations; Provide line clearances after satisfactory review BMR: Plan for in-process sampling as per production schedule.

Engage with employees; Direct and guide team on departmental issues; provide on-job training to team members.

Good handling & troubleshooting knowledge of various laboratory equipments.

Identifying scope for implementation & monitoring of technological changes to enhance productivity.

Identify, evaluate and implement continual improvement excercise to improve productivity as well as simplify systems & procedures .Ex-automation process or reduced testing, increase shelf life inorder to ensure quality improvement and reduction in lead times, better product availability and reduced cost of poor quality and productivity.

Executing cost saving techniques / measures and modifications to achieve substantial reduction in Lab by TQM technique.Expenditures and work within the targeted budget.

Review of Standard operating procedure, Specifications and Standard testing procedures .

To ensure all the operation are conducted as per SOPs.

Review of Analytical method validation protocols and Reports.

Optimum utilization of staff and resource with very good planning.

Liable for cGMP activities, following up the cGLP, regulatory guidelines with the related documentation work.

Achievements:

Reduced of repetitive unconfirmed OOS.

Timely completion of Lab investigations and reduced of repetitive lab events.

Training provided and development of the QC lab analysis to reduced 50 % of human error and Instrument related error.

Instrument breakdown minimized and Proper Maintenance of QC laboratory Instruments.

HPLC and GC Method issue identified

5.NURAY CHEMICALS PVT LTD, CHENNAI.(Oct-2012 to Nov-2016)

MANAGER (QUALITY CONTROL)

The Company:Nurayis one of the big players in Bulk drugs and Generic products having a Collaboration with Par Pharmaceuticals,standard like USDFDA,WHO,regulatory agencies.

The Accountability& Attainments

Liable for cGMP activities, following up the cGLP, regulatory guidelines with therelated documentation work.

Review the analytical reports & ensure the batches manufactures are in compliance with the same and the licence & statutory requirements are met . Flag product stability issues / failures to the supervisor & seek guidance for appropriate action.

Review and approval of Specifications and Standard testing procedures and Annual Product Quality Records.

Development of Analytical methods and Validations.Review and approval of Analytical method validation protocols and Reports.

Identify, evaluate and implement continual improvement excercise to improve QA productivity as well as simplify systems & procedures .Ex-automation process or reduced testing, increase shelf life IN ORDER TO ensure quality improvement and reduction in lead times, better product availability and reduced cost of poor quality and productivity.

Review of documentation prior to product release . Approve / reject quality Notifications such as, Incident, Change control, OOS etc in a quality and timely manner, ensure investigations of failures / complaints and response to stakeholders.

Achievements:

Updated the Quality procedures inline with the regulatory guidelines.

Addressed USFDA deficiencies coordination with RA.

4.SHASUN PHARMACEUTICALS LTD. (Feb 2012 to Oct 2012)

ASSISTANT MANAGER (QUALITY CONTROL)

The Company:Shasun is one of the big players in Bulk drugs and formulation having a standard like USFDA,MHRA,WHO,EU,KFDA,Mexican FDA and audited by all major International regulatory agencies.

The Accountability& Attainments

Liable for cGMP activities, following up the cGLP, regulatory guidelines with the related documentation work.

Guide & monitor the team in reviewing,facilitating & adhering to quality systems related with product stability & intimate regulatory authorities (internal & external) in case of failed studies on a pro-active basis.

Review the analytical reports & ensure the batches manufactures are in compliance with the same and the licence & statutory requirements are met . Flag product stability issues / failures to the supervisor & seek guidance for appropriate action.

Guide & monitor the team in ensuring compliance for planned events such as revalidation as per validation master plans, calibration,preventive maintenance plans ; for events such as any changes in the area, equipment or process involved in the plant. and also in case of introduction of new products or any other unplanned events IN ORDER TO ensure the facility & processes are in validated state.

Enforce Budgetary discipline in the function.

Coordinate with Marketing/R&D depts. when required for resolving conflicting market requirements and priorities.

Identify, evaluate and implement continual improvement excercise to improve QA productivity as well as simplify systems & procedures .Ex-automation process or reduced testing, increase shelf life IN ORDER TO ensure quality improvement and reduction in lead times, better product availability and reduced cost of poor quality and productivity.

Review of documentation prior to product release . Approve / reject quality Notifications such as, Incident, Change control, OOS etc in a quality and timely manner, ensure investigations of failures / complaints and response to stakeholders.

Optimum utilization of staff and resource with very good planning.

Achievements:

Prepared the plant to attain USFDA, WHO (Twice),KFDA and Mexican FDAapprovals.

Addressed the various regulatory (USFDA,EUGMP,WHO)deficiencies coordination with RA.

3. SENIOR EXECUTIVE(E4 LEVEL)– AUROBINDO PHARMA LTD,VISAKHAPATNAM

(Apr 2008 – Feb 2012)

The Company:Aurobindo Pharma is one of the big players in API having a standard like FDA,MHRA,WHO, and audited by major international regulatory agencies.

Responsibilities:

Responsible for Charging and analysis of Holding time study.

Monitoring the QC activities as per the requirement of GLP guideline.

Providing technical guidance and training to all subordinates working in the department.

Timely dispose the leftover samples after analysis.

To ensure all the operation are conducted as per SOPs.

Responsible for training and analyst validation for all employees.

Any other work delegated by superiors.

To maintain all the Instruments And equipments are in working condition.

Responsible for monitoring and reviewing all cleaning Validation and Analyst Validation activities and its Documentation.

To ensure deviations if any are documented explained, investigated and report to Manager for corrective action.

Coordinating with related departments during internal audits quality review and other exercises.

Responsible for the preparation of audit compliances reports and OOS Investigation.

Authorized To sign in the place of Checked by and also sign in the place of Approved by all in process, Raw material and intermediate, finished products documents in the absence of HOD.

2. QUALITY CONTROL EXECUTIVE-SRI KRISHNA PHARMACEUTICALS LTD,

SRI KRISHNA DRUGS LTD, HYDERABAD.

(Mar 2007 – Apr 2008.)

The Company: Srikrishna Pharma is one of the big players in API having a standard like FDA,MHRA,WHO, and audited by major international regulatory agencies.

Responsibilities:

Preparation and review of standard testing procedures (STPs) and Standard operating Procedures (SOPs).

Review of all instrumentation related logbooks.

Preparation and review of all work sheets related to in process and Finished product analysis. Planning and organizing of in process and finished product analysis.

Team member in self-inspection team for GMP internal audits.

Section In-charge for the Instrumental Analysis Laboratory and Wet analysis Laboratory.

Analysing day-to-day samples of raw materials/Packing materials/in process/finished products/stability/validation samples as per specifications.

Conducting laboratory instrument calibrations.

Conducting Preventive maintanance program for Laboratory instruments.

Achievements:

Updated the Procedures as per regulatory guidelines.

1. QUALITY CONTROL EXECUTIVE - COVALENT LABORATORIES (P) LTD,

HYDERABAD.

(Aug 2003 – Mar 2007.)

The Company: Covalent laboratories is one of the big players in API having a standard like WHO, and audited by major international regulatory agencies

Responsibilities:

Analysing day-to-day samples of raw materials/Packing materials/in process/finished products/stability/validation samples as per specifications using Microbial techniques and Instruments like HPLC,GC,UV,IR.

Executing analytical method transfers&validations.

Conducting Laboratory instrument calibrations.

Conducting Preventive maintanance program for Laboratory instruments.

Handling Inventory management in the laboratory;executing assigned work activities as per sample plan;recording and reviewing analytical data.

Achievements:

Prepared the plant to attain WHO GMP approvals.

Key personal attributes:

Ability to develop and initiate policies and systems to ensure operationalexcellence.

Good interpersonal and networking skills.

Self- motivated with strong problem solving skills.

Able to manage, guide, train and motivate a team.

Good leadership qualities and managerial skills.

Creative and innovative.

Analytical and logical thought process.

Operating Network:

Internal – QA, RA, R&D, Marketing,HR,IT,Finanace.

External - Regulatory bodies, Customers, Vendors.

ACADEMIA

Graduate (B.Sc.Chemistry) inscience from Bharathidhasan Universityin 1997-TN.

Master Graduate (M.Sc.,Chemistry) in Sciencefrom Annamalai Universityin 1999- TN.

P. G. Diploma in Industrial Water and Waste ( Water Treatment) from Alagappa University in 2000-TN.

PERSONAL DETAILS

Marital Status : Married

Permanent Address : 15, Thilagam Nagar,

Varichikudi,

Kottucherri, Karaikal.

Pondichery.

India, PIN-609609

Passport No : K433690

Date of Issued : 05-03-2013

Valid upto : 04-03-2023

Place of Issued : Chennai

REFERENCE:

1. Mr. D.Balasubramanian, 2.Mr. A.Saravanan,

Head- Qc, Head- Qc,

Dr. Reddy's Labratories Ltd, Nuray Chemicals pvt ltd

Visakhapatnam. Thiruvallur,Chennai.

Ph.: +919********* Ph.: +918*********

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