RESUME

MANOJ KUMAR VERMA

Mobile: 955-***-**** / 972-***-**** / 941*******

E-Mail: adjky6@r.postjobfree.com / adjky6@r.postjobfree.com

OBJECTIVE

Seeking the suitable position in quality department, where my knowledge and experience will enhance productivity and effectiveness of the organization through dedicated efforts, competency and hard work.

PROFILE SUMMARY

Over 13 years’ experience in Pharma industry in Q.C. department.

Lead the quality control activities to ensure timely testing and release of all samples.

Oversee the laboratory for GMP and safety compliance.

Approved in Chemical & Instrumentation from H.P. State Drug Controller Dept.

Exposure of US-FDA, EU, MHRA, WHO Geneva and others regulatory audits

Exposure in all sections of Q.C. and exposure of Laboratory Setup.

Well exposure of QMS (i.e. CAPA, OOS, OOT, deviations, incidents, change controls & Risk assessment etc.

Good communication and human relation skills.

Hands-on experience in all modern instruments such as HPLC, GC, IR, UV, Karl Fischer, Autotitrator, Dissolution etc. as well as various other analytical techniques.

Capital expenditure plan for laboratory equipment, chemicals, glassware, reference standards etc.

SKILLS

CSV, Calculator Validation, Analytical method validation, Excel Sheet Validation, Exposure of US-FDA, EU, MHRA audits, exposure of modern instruments such as HPLC, GC, IR and Trainings.

PROFESSIONAL EXPERIENCE

Since Jan-2018, Mankind Pharma Ltd, Paonta Sahib as Assistant Manager–Q.C. (GLP & Compliance)

EU, PICS & MCAZ etc approved unit, manufacturing of Tablets, Capsules & Oral liquid.

Responsibilities:

To manage and plan the GLP & Compliance related activities.

Manage and procurement of Reference Standard, Working Standard and impurities.

Review and approval of SOPs, Specifications, STPs.

To participate and documentation of the internal and external audits and response to the audits to ensure compliance.

Ensure the analyst qualifications.

Training to the QC persons on SOPs and regulatory updates.

Responsible for the safety compliance in laboratory.

Oct-14 to Dec-17, Nectar Life Sciences Ltd, Baddi as Assistant Manager–Q.C. (FG Section in-charge)

US-FDA, EU approved unit, manufacturing of Injections, Tablets, Capsules & Oral.

Key Result Areas:

To manage and plan the analysis and release/ approval of finish goods and semi finish goods.

Conduct lab investigations i.e. OOS, OOT and Deviations etc.

Handling of internal and external audits.

Responsible for Method Validation/ Verification etc.

Aug-2012 to Sep-2014, Pfizer Ltd. (Zoetis Ltd), Haridwar as Executive –QC (Stability Section in-charge)

PICS, MCC & MCAZ approved unit, manufacturing of Tablets, Liquid & Injection.

Key Result Areas:

To manage the stability studies as per guideline, method validation & tech. transfer related activities.

Stability Chamber management.

Aug-2009 to Jul-2012, Panacea Biotec Ltd., Baddi as Executive – QC (Raw Material Section)

US-FDA and EU approved unit, manufacturing of Tablets, Capsule & Ointments.

Key Result Areas:

Responsible for raw material section, analysis and review of reports.

May-2007 to Jul-2009, Macleods Pharmaceuticals Ltd., Baddi as Senior Officer-QC

US-FDA, EU and WHO Geneva approved, manufacturing of Tablets, Capsule & oral

Key Result Areas:

Analysis of finish, raw material packaging and water samples.

Sampling of raw materials, packing material & waters samples.

ACEDMIC QUALIFICATION

M.Sc. (Analytical Chemistry) in 2005 from Gurukul Kangri University, Haridwar with 70 % marks.

B.Sc. (Biology) in 2002 from C.C.S. University, Meerut.

AUDIT FACED

US-FDA, MHRA, ANVISA, EU, TGA, PICS, MCAZ, WHO Geneva & MCC etc.

TRAINING

Six Sigma “Yellow belt” training in Pfizer Ltd.

SMED training in Mankind Pharma Ltd.

PROJECT TRAINING

On ‘WD-XRF’ technique from Wadia Institute from October-2005 to March-2007.

PERSONAL STRENGTH

Team building / Leadership skill, Transparency, Positive Thinking & Ability to work in multicultural environment.

ACHIEVEMENTS

Rewarded for continuous improvement ideas given to operation excellence in Pfizer India Ltd and Mankind Pharma Ltd.

PERSONAL DETAILS

Date of Birth : 4th January, 1981

Languages Known : Hindi & English

Marital Status : Married

Address : Village – Amiliha, Post – Bilkhia, District Barabanki –225305, U.P.

Current CTC : 10.7 L/ A

Expectation : As per company norms (Negotiable)

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