Medical Records Quality Assurance

DISHA D. HARMALKAR

Mobile: +1-848-***-****

E-Mail: ***************@*****.***

**************@*****.***

CAREER OBJECTIVE

To add value to the organization and to obtain a responsible position in a dynamic pharmaceutical company and information technology which can provide an opportunity to fruitfully employ my skills and foster an atmosphere of continual learning.

PROFILE SUMMARY

• Worked at IT cube Technologies, Pune, India from August 2021 till July 2023.

• Worked at Cipla Pharmaceuticals, Oncocare, Goa,India from November 2007 till November 2010.

• Worked at FDC unit III, Goa, India from December 2006 till October 2007.

• Worked at Glenmark Pharmaceuticals, Goa, India from June 2004 till December 2006. PROFESSIONAL EXPERIENCE

At ITcube technologies, Pune, India. (August 2021 till July 2023) Designation: Medical data summarizer/executive.

• Maintain security of medical records to ensure confidentiality is maintained.

• Experienced in medical records file management as per medical regulatory requirements.

• Reviewing records for completeness, accuracy and compliance with regulations.

• Manage and update patient records, including medical histories, treatments and examinations.

• Compile and analyze emergency room patient records.

• Compile and analyze radiology reports.

• Collaborate with colleagues to manage and prioritize work flow.

At Cipla Pharmaceuticals, Oncocare unit V, Goa. ( November 2007 till November 2010) Designation: Quality Assurance Officer.

• Involved in the preparation of master BMRs and BPRs through production system for domestic and regulated market.

• Involved in review of BMRs BPRs for domestic and regulated market.

• Handling change controls for change in procedure, documentation and process.

• Handling of online rejection note.

• Handling of Training programs for QA department personnel.

• cGMP compliance and Investigation of deviations.

At FDC, unit III, Goa. ( December 2006 till October 2007) Designation: Quality Assurance Officer.

• Online review of BMRs for packing process.

• Review of BPRs for dispatch of pharmaceutical products for sale.

• Periodic audits in packing material stores raw material stores and quality control department.

• Preparation of stability protocols and reports for existing and new products for domestic market

.

• Review of stability data.

• Handling of online rejection note.

• CGMP compliance and Investigation of deviations.

At Glenmark Pharmaceuticals, Goa. ( June 200 till December 2006) Designation: Production/Packing Officer.

• Preparation and review of departmental SOPs.

• Preparation and execution of Packing BPRs for ANDA Submission and commercial production.

• Handling a team of junior officers and operators responsible for packing functions.

• Handling of Training programs for junior officers and operators. Preparation and execution of Standard operating procedures, Operational Qualifications (OQ) and Batch Production records.

• cGMP compliance and Investigation of deviations

• Handling, investigation and response to market complaints.

• Generation of requests for preparation of Bill of materials for new products through SAP.

• Raising change controls for change in procedure, documentation and process.

• Knowledge in Blister packing machine, Strip packing machine and CVC Container filling line.

• Around 2 years of experience in handling different International Quality Audits EDUCATION

2004 Bachelor of Pharmacy (B. Pharm.) from Goa college of Pharmacy, Goa University. 2020 Diploma in Education ( Teachers Training Program) in Educon International School, Pune. AUDITS FACED

• USFDA, WHO ( INDIA), LACHMAN (US), CANADA (TPD), QUINTAL( UK), ENVISA( Brazil) and M.C.C. PROFESSIONAL SKILL SET

• Thorough Knowledge of GMP and conventional guidelines for pharmaceutical manufacturing and Packing.

• Conversant with SAP R/3.

• Conversant with Windows XP, MS Office.

PERSONAL INFORMATION

Nationality : Indian

Marital Status : Married

Sex : Female

Language Fluency : English, Marathi, Konkani and Hindi. Leisure Activities : Reading and Listening to Music. Date of Birth : 5th July 1982

ADDRESS

1110, Gill lane apartment. Cheryl drive, Iselin 08830. New Jersey, USA. REFERRENCES

Mr. Sanjay Singh Negi

Mr. Rohan Sardessai

Mr.Shivaji Salgaonkar

Mr. Chaitanya Kale

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