AU: ANKIT UJJWAL

Email: adgumi@r.postjobfree.com

Current Address: Sahil Kanha Park, Rau, Indore, M.P, India

Mobile: +91-777*******

PERSONAL SUMMARY

I highly motivated and results driven quality executive who has about 7.3 years of valuable experience in leading and developing a successful quality team. Skilled in numerous operational and quality fields including CAPA management, Vendor management, Sampling matrix, Hold time protocols, KPI’s, Stability protocol, BPR review, TAT management, Handling of complaints, Handling of audits etc. Having the ability to handle complex assignments effectively and possessing the confidence to work as a team or independently.

I am presently looking for suitable opportunity position with a forward thinking company that has a friendly and vibrant atmosphere where I can excel in my career.

WORK EXPERIENCE

Current work: Executive in Quality Control at Glenmark Pharmaceuticals ltd, Indore, India

April-2018 to till date

Skills:

Established planning & performed the complex analysis for stability samples, hold time samples, finished product samples.

Handled HPLC, UV, Dissolution apparatus, and Auto titrator.

Investigated and Reviewed Incidents, OOS, OOT, Change Control and CAPA’s for Quality control department ‘ON LINE’.

Verified the compliance against identified QA/QC SOP’s.

Ensured the daily monitoring of stability chamber in different storage conditions.

Imparted training in various sections.

Involved in CAPA management.

Previous work: Executive in Quality Control/Quality Assurance - Compliance at Glenmark Generics ltd., Buenos Aires, Argentina, South America

Sept-2016 to March-2018

Skills:

Established Key Process Indicators (KPI’s)

Tracked and reported quality metrics for all the CPP’s (weekly and monthly).

Ensured to conduct the annual training for GMP, GDP, and Eudralex etc. to all the employees.

Prepared internal and corporate quality documentation and reports by collecting, analyzing and summarizing trends for failed processes, stability studies, recalls and corrective actions.

Tracked each CAPA’S and their effectiveness in the plant.

Ensured to update the Site Master File in every six month.

Participated in the internal audit among respective departments as per yearly planner.

Involved in QC incidents, OOS, OOT, Change control.

Made planning for stability samples to different analyst to conduct physical and chemical tests.

Reviewed and approved the Test Data Sheet as per STP in OPEN TEXT SOFTWARE.

Ensured the TAT (Turn around Table) for daily deliveries, like: GRN to- Sampling to-Testing to- Release for RM and PM.

Conducted the analyst qualification for a new candidate.

Ensured the accountability of reagents stock and share the data with Verifarma.

Ensured the GLP in the routine activities.

Reviewed & approved the stability summary report as per the stability protocol.

Reviewed, evaluated & approved the LER (Laboratory error report).

Vendor management.

Previous work: Sr. Officer in Analytical QA at Glenmark Pharmaceutical ltd., Indore, M.P, India

Aug-2014 to Aug-2016

Planned and coordinated activities related to Quality control at site.

Investigated the Incidents, OOS, OOT, Change Control at different stages in SAP.

Reviewed of raw data’s at different stages of analysis: IPC, SFG’s, FP’s, hold time, stability reports.

Reviewed AMV report in different stages.

Investigated LER on-line.

Ensured effectiveness of CAPA’s.

Previous work: Officer in IPQA at Glenmark Pharmaceutical ltd., Indore, M.P, India

July-2012 to July-2014

Ensured timely line clearance for batch dispensing, manufacturing and packaging.

Ensured timely sampling and submission of Blend samples, semi-finished samples, finished samples, hold time, control samples, stability samples and swab samples.

Ensured online execution of BPR’s at the shop floor.

Reviewed for Executed and Intended BPR’s.

Timely initiation of stability request and sampling matrix.

In process sampling, testing and documentation of IPQA activities.

Withdrew and submitted PQ/Validation samples to QC.

Performed the in-house Calibration of IPQA equipment’s like Friability, D.T, Auto tester, weighing balance etc.

Ensured swab for different equipment’s.

Previous work: Jr. Officer in QA Documentation cell at Glenmark Generics ltd., Indore, M.P, India

Aug-2011 to June-2012

Issued controlled copy documents for STP, Specifications, GTP, SOP’s, Workbook, Scale up BPR, Intended BPR, TDS, Validation protocol etc. to the stake holders.

Archival and Retrieval of Executed Documents.

Destructed un-controlled copy documents.

Training management: Co-ordination for induction training to the new employees and co-ordination for annual training and co-ordination for any SOP’s training.

Audit compliance: ATR for internal or external audits

Prepared Monthly report

Tracked and trended of activities related to documentation cell.

Ensured SOP’s for its revalidation or next revision before due date.

Tracked signature specimen record for the new employees.

Previous work: Previously exposed with various pharmaceuticals like Erawat pharma, Lupin pharma, Promed pharma & Pure pharma.

EDUCATIONAL QUALIFICATION

June 2009 to April 2011 M.Pharmacy in Pharmaceutics at Prist University, Tamil Nadu, India

June 2005 to April 2009 B.Pharmacy at Sri Satya Sai college of pharmacy, Madhya Pradesh, India

April 2003 to May 2005 12th class at SMD College, India

Mar 2002 to Mar 2003 10th class at Kendriya Vidyalaya, India

ACADEMIC CONFERENCES PARTICIPATION IN INDIA

P.S.G. College, Coimbatore, International Conference (Tamil Nadu, INDIA)

Perriyar College of Pharmaceuticals Sciences, Tricy, National Conference (Tamil Nadu, INDIA)

Annamalai University, Chidambaram, National Conference (Tamil Nadu, INDIA)

Prist University, Thanjavur, International Conference (Tamil Nadu, INDIA)

Prist University, Pondicherry, National Conference (Tamil Nadu, INDIA)

Attained Indian Pharmaceutical Congress 2010, Manipal (Karnataka, INDIA)

COMPUTER SKILLS

Familiarized with Microsoft Word, Microsoft Excel and Microsoft Power Point

Familiarized with SAP and open text software.

PERSONAL PROFILE

Father’s Name: Sri Arun Kumar Gupta

Date of Birth: 28th March 1987

Nationality: Indian

Gender: Male

Religion: Hindu

Mother tongue: Hindi

Marital status: Married

Languages Known: Hindi, English & Little Spanish

Hobbies: Seeking for Innovative Ideas, Making Friends, Travelling.

REFERENCES

Available on request.

DECLARATION

I hereby declare that the details furnished above are true and correct to the best of my knowledge and belief and I undertake to inform you of any changes therein, immediately. In case any of the above information is found to be false or untrue or misleading or misrepresenting, I am aware that I may be held liable for it.

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