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MAHALINGAM

adm2yi@r.postjobfree.com

Cell: 909-***-****

PROFILE: SENIOR MANAGER - QUALITY CONTROL (FORMULATION) Accomplished QC professional with 21 years of progressive experience with proven record of significant and successful contribution in quality control (Pharmaceutical formulation) in a wide range of companies. A highly trained individual; excellent interpersonal skills; can manage analytical issues and able to resolve effectively; ability to meet deadlines; great attitude towards work and ensures all standards are met. AREAS OF EXPERTISE INCLUDE

• Exposure of working in

USFDA/EU/MHRA/ANVISA/WHO

(Geneva) Regulated environment.

• OOS/OOT/OOC/Incidents

/Deviations/CAPA/Change

Control

• Stability study

• Audits (US FDA -12, MHRA-9, EU

(GMP) – 5, ISO 9001 – 1, WHO-

(Geneva) -1 Includes sterile and non

sterile regulatory audits.

• SAP/ERP/LIMS/QMS

/EDMS/LMS/EWS

• Qualification and

Calibration of

Instrument

• 16 years of working in sterile plants and 16

years in non-sterile plant

• Data Integrity • Documentation

• Chemical/Instrument analysis • Method validation/Method transfer

• Compliance

• Process validation • New Lab Projects • Analytical problem resolution

PROFESSIONAL EXPERIENCE

Sun Pharma Baska Halol Aug- 2017 to Apr 2020

Senior Manager – Quality control (Formulation)

• Handled team size of 60 +.

• Plan, coordinate and direct quality control program designed to ensure continuous production/service consistent with established standards.

• Exposure in EDMS/LMS/LIMS.

• Review and Approval of documentation associated with Deviation, OOS/OOT, Market Complaints, customer notifications, Product Recalls, CAPAs, Change Controls, Returned Goods, SOP’s, Protocols, reports .

• Active participation in investigations.

• Resolution of Quality issues.

• Review and Approve Specification/STP, SOP, method transfer/validation protocols and reports. MAHALINGAM • Cell: 909-***-**** adm2yi@r.postjobfree.com Page 2 of 4

• Ensure required initial and continuing training of the department personnel is carried out.

• Ensuring QC personnel Conduct, Safety and good quality control practices in the laboratory.

• Monitoring of chemical, physical test procedures and results.

• Periodic review of key systems and procedures and suggest improvements to ensure fully compliance.

• Timely testing and release of Exhibit batches, Raw materials, In-process samples, validation samples, stability samples and Finished product.

• To conduct Method validation /Method transfer studies as per written protocol.

• Analyzes and resolves work problems

• Ensuring QC equipments calibrated (internal and external) and maintained as per timeline.

• Training of analyst according to yearly training plan and SOP based training.

• To keep lab all time ready to handle audits.

• Approval of Finished product, Validation, In process, rinse and swab samples, packing material and raw material test reports.

• Ensuring availability of laboratory requirement.

• Maintenance of log books, registers, reports.

• Escalation of quality issues like OOS, OOT, deviation and OOC.

• Ensuring compliance of system and documents.

• New Lab project

• To ensure regulatory commitments and requirements.

• May recruit, hire, train staff, evaluate employee performance, and recommend or initiate promotions, transfers, and disciplinary action

FDC Ltd, Baddi Jun-2014 to Jun-2017

Senior Manager - Quality control (Formulation)

• Successfully faced Netherland and US FDA audit with no 483.

• Played pivotal role in the implementation of LIMS and SAP.

• Handled a team size of 40 +.

• Strengthened data integrity by implementing procedures, updating technology and making the personnel aware of data integrity issues.

• Introduced and revised more than 70 SOP’S

• Strengthened Quality Management System.

• Increased the QC productivity.

NECTAR LIFESCIENCES Ltd, Baddi Aug-2013 to Jun-2014 Senior Manager – Quality control (Formulation)

• Successfully directly handled WHO (Geneva),US FDA/EU/ GMP(Portugal)/Nigeria/Japan / Uganda/Ghana/Vietnam/US FDA consultant (PARAXEL)/ WHO GMP/Merck Soreno (Italy ) audits.

• Managed a team of 90 +

• Overall responsibility of analytical testing and release of raw materials, packaging materials, In-process, finished products and stability testing

MAHALINGAM Cell: 909-***-**** adm2yi@r.postjobfree.com Page 3 of 4

MANKIND PHARMA Ltd Paonta Sahib Dec-2010 to July- 2013 Head – Quality Control (Formulation)

• Successfully faced Kenya/Nigeria/WHO GMP audits

• Managed a team of 40 + and ensured timely release of Raw materials, In-process samples, process validation samples, cleaning validation samples and Finished product.

• Review and approval of specifications, sampling instructions, test methods and other QC procedures.

• Played pivotal role in the implementation of SAP.

• Introduced more than 40 new SOP’s

• Overall responsibility of analytical testing and release of all raw materials, packaging materials, In- process, finished products and stability testing

MACLEODS PHARMA Ltd Baddi Nov - 2009 to Dec-2010

Asst Manager – Quality Control (Formulation) – IP/ FP/ANDA section

• Faced successfully WHO (Geneva), MHRA/USFDA/Ghana/ Oman/Ukraine audits

• Managed a team of 25 + members planned and executed release of Inproces samples, process validation and Products for domestic, ROW, South Africa, EU and ANDA products as per timelines.

• Planned and executed more than 50 + ANDA batches analysis.

• Handled incidents/deviations/OOS.

• Part of team which increased monthly turnover from 15 crores/month to 120 crores/month. WOCKHARDT Ltd Aurangabad Aug-2005 to Sep-2009

Group Leader – Global Method Transfer

• Transferred more than 52 products analytical methods from Wockhardt (UK), Pinewood (Ireland) to Wockhardt Indian locations.

• Analytical method validation,

• Vendor qualifications,

• Handled steroid formulations,

• Participation in the preparation of GCC/US FDA/MHRA audit at several locations. USV Ltd Daman Apr-2002 to Sep-2005

Sr Officer – Quality control (Formulation)

• Faced USFDA, EU GMP (Finland), several African and Asian regulatory audits successfully.

• Incharge for Laboratory support (Handling of Reference standards, working standards, volumetric solutions, General reagents, Column management, Preparation of SOP’s. Calibration of Instruments, Annual preventive maintenance)

• Incharge for IP/FP/ANDA Section.

• Analyzed In-process samples/Finished products/ANDA batches.

• Introduced around more than 50 SOP’s

MAHALINGAM • Cell: 909-***-**** adm2yi@r.postjobfree.com Page 4 of 4

Tablets India Ltd Chennai Feb-1998 to Mar-2002

Analytical Chemist - Quality control (Formulation)

• Faced numerous audits including ISO9001/Nigeria/Kenya/Ghana/GSK/ WHO /UNICEF etc

• Performed HPLC analysis of Raw materials, In process samples, Finished product.

• Highly experienced in the amino acid analysis

• Developed analytical methods for Amino acid formulations.

• Performed MLT, Environmental monitoring, Antibiotic analysis, Vitamin analysis, LAL testing, pyrogen testing, Toxicity testing, Sterility testing. EDUCATION

Bachelor of Pharmacy [1992 – 1996] Annamalai University, Tamil Nadu, India TRAINING

GMP, GLP, Data integrity, Situational Leadership, QMS, Steven covey’s 7 habits of Highly effective peoples, HPLC, OOS, OOT, Deviation, AQbD, Quality Control process improvement. SOFTWARE SKILLS

Microsoft word, Microsoft Excel, Microsoft powerpoint, Lotus notes, Outlook, ERP, LIMS, QMS, EDMS, LMS, EWS and SAP.

LANGUAGES

Written and spoken : English, Tamil

Spoken : Hindi

HOBBIES

Listening to Music, Philately, Reading books, Watching sports programs, PERSONAL DATA

Father’s Name : Late M . Govindaraju

Date of birth : 30.06.1973

Address : No : 14, Taj Nagar, Keezhakasakudy, Karaikal, Pondicherry – 609609, India. DECLARATION

I hereby declare that the above furnished details are true to the best of my knowledge. DATE:

PLACE: (G. MAHALINGAM)

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