Quality Control Analyst

CURRICULUM VITAE

Miss. Sadhna

Mobile: +919*********

E-mail: ************@*****.***

Objective

Seeking for the position in Quality Assurance/Quality Control to utilize my experience and knowledge to serve the organization in its best interest.

Professional Experience

Total experience of 07 years in the field of pharmaceutical formulation units, Quality control Department.

Currently working with Unichem laboratories limited since July 2014, as an Executive Quality Control Unichem Laboratories Ltd. Ghaziabad is certified by USFDA, MHRA UK, ANVISA Brazil, WHO and other regulatory authorities.

Worked with Laborate Pharmaceutical India Ltd. Paonta Sahib Distt. Sirmour, (H.P.) as an Officer Quality Control since October 2013 to July 2014. This unit is certified by WHO, cGMP, ISO Approval.

Worked as an Officer-QC with M/s Elnova Pharma India, Kala-Amb, and Distt. Sirmour, (H.P.) since Sept. 2011 to October 2013. This unit is certified by cGMP, ISO Approval.

Academic Qualification

M Sc. Biotechnology (honors) from Lovely Professional university Jalandhar (Punjab) in 2011 with First Div.

B Sc. Biotechnology from DAV College Jalandhar affiliated by Guru Nanak Dev University Amritsar (Punjab) in 2009 with First Div.

Intermediate from Punjab School Education Board in 2006 with Second Div.

High School from Punjab School Education Board in 2004 with First Div.

Diploma in Computer Application and Programming in 2011 with First Div. (Corresponds Study).

Major Achievements

Unichem Laboratories Ltd. Ghaziabad

1)Achieved the Certificate of Trainer to impart the trainings on Functional and operational SOPs and analytical techniques with demonstration, GLP trainings to Lab and awareness of data integrity.

2)Appreciated as Best performer of USFDA audits.

3)Trained the QC personnel to perform the analysis and documentation as per regulatory requirement.

4)Delivered Analytical method transfer of Products (Olmesartan Medoxomil, Valsartan Hydrochlorothiazide, Chlorthalidone Tab, Carvedilol Tablets, Levetiracetam Tablets with revised procedure in USP, etc.)

5)Successfully delivered the Analytical Method Verification for ANDA product (Vortioxetine Bromide Tablets USP 5mg, 10mg and 15 mg).

6)Achieved a certificate in Project management training.

M/s Elnova Pharma India

1)Deep learning of handling of core analytical techniques and handling of sophisticated instruments.

Current Job Responsibilities

The complete responsibility of Finished product department along with planning, work allotment and review of finished product data.

Responsible for finished product commercial batch release by maintaining the full compliance level in a reasonable period.

Handling of any Out of specification/Out of trend result and lab events in QC.

Responsible for any regulatory audit with all time readiness for external and internal inspections.

Individual responsibility of analyst qualification and analyst validation.

Focus on campaign testing to achieve OTIF.

Providing the Training to analysts to work in discipline and decorum to be maintained by avoiding any unplanned leave and work as per regulatory requirements with no data integrity.

Responsible for critical analysis and lab investigations in any OOS/OOT or any event to find out the root cause.

Laboratory Analysis

1) Vast experience in Analysis of semi finish samples, finish samples, process Validation samples, Hold Time, Stress Study samples.

2)Operation and calibration of all Laboratory Instruments like Chromatographic (HPLC,UPLC,GC), Spectroscopic (UV,FTIR), Optical analysis (SOR), Dissolution test apparatus, Disintegration test apparatus, Karl Fischer, Tap density apparatus, Melting point, refractometer, pH meter, weighing, sieve analyzer.

3)Periodic maintenance and Preparation of Working standard.

4)Preparation and standardization of volumetric solutions, test solutions and indicators.

5)Sound knowledge of analysis of different Dosage forms: Tablets, Soft Gelatin Capsule, Hard Gelatin Capsule, Syrup, Injection, oral suspension and ointment.

Documentation

Sound knowledge Reporting system, Documentation, Result verification & report preparation and maintenance of instrument log books and inwards.

Having the experience to present and explanation of reports.

Good knowledge of compilation of documents.

Preparation of COA, data entries through LIMS.

IT/Tools Software Known

Tools: LIMS, SAP, Pharma Suit, MS office, MS excel, MS power point, Net surfing.

Operating system: Windows 07,Window 10, Windows XP.

Audit Faced

USFDA: 3 Times

Faced USFDA -2018, MHRA-2017, US- FDA -2017 and Ukraine as a Finish Product Group Leader.

Faced PICS - 2017 audit as reviewer and planner.

Faced US- FDA -2015 as a Analyst in Unichem Labs Ltd.

Faced PHARMA SCIENCE- CANADA, in 2015 in Unichem Labs Ltd.

Faced ANVISA, FDA-GHANA, and FDA-YUGANDA in year 2016 in Unichem Labs Ltd.

Successfully faced audit Regulatory audits/CQA Audits, Mylan Pharmaceutical Ltd. at Unichem labs ltd. Ghaziabad

WHO at Laborate Pharmaceutical India Ltd. Paonta Sahib (HP).

cGMP and other International regulatory Authorities in M/s elnova pharma (HP).

Strength

Excellent team leader with team building capability, Commitment, Loyalty and good motivator.

Creative and independent initiative good judgment Determination, Self Deployment and Flexibility.

Good interpersonal and influencing skills.

Personal Detail

Date of Birth :17th Nov, 1988

Father’s Name : Mr. Charan Dass

Mother’s name : Mrs. Raj Kumari

Marital Status : Single

Language Known : Hindi, Punjabi & English

Nationality : Indian

Gender : Female

Salary expectation : Negotiable

Bonafide : Punjabi

Permanent Address

Miss Sadhna, D/O Mr. Charan Dass

Vill.- Brahmpur, Tehsil-Nangal

District-Ropar, Punjab-140125

Sadhna

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