Quality Assurance Specialist

CAREER OBJECTIVE: Looking for a coop opportunity, with my diversified experience and GXP knowledge, I can contribute effectively towards quality compliance in an ever changing regulatory framework of a multi-product market

EDUCATION:

Northeastern University, Boston, MA, USA September 2015 - Present

MS in Regulatory Affairs in drugs, biologics and medical devices

Amity University, NOIDA, UP, INDIA July 2011 – June 2013

MS in Pharmaceutics

Andhra University, Visakhapatnam, Andhra Pradesh, INDIA October 2007 - May 2011

BS in Pharmacy

INTERNSHIP:

Indus Hospitals, Visakhapatnam, Andhra Pradesh, INDIA August 2010 - March 2011

Title: Clinical case study on anti-hypertensive drugs

PROJECT:

Dr. Reddy’s lab, Visakhapatnam, AP, India February 2009 - December 2009

Title: Formulation, development & evaluation of Pulsatile Drug Delivery System (PDDS) of an NSAID for the treatment of rheumatoid arthritis

EXPERIENCE:

Lee Pharma, Visakhapatnam, Andhra Pradesh, INDIA

Quality Assurance Analyst August 2013 – May 2015

Ensured that all shop floor activities are in GMP and cGMP compliance and documented as per established standards

Ensured that GXP quality documents are process controlled to ensure compliance. All quality documents such as log book, batch records, validation protocols, stability protocols, standard operating procedures of equipment/ facility/ validation documents, technical specification etc. are prepared, checked and updated

Looked after batch disposition activities such as ensuring release of raw materials, packaging and labelling of finished products are in cGMP compliance and verified batch records for final approval

Actively assisted in document life cycle management and document destruction, to assure controlled document quality system management standards are met

Successfully assisted in investigating root cause analysis of deviations and documented such findings. Also, looked into Out of Specifications, Out of Trend complications and implemented Preventive Maintenance Procedures.

Worked on deviation management and assisted in impact assessment, root cause analysis and CAPA measures to assist in standard change control.

Meghana Pharmaceuticals, Hyderabad, Telangana State, INDIA

Quality Assurance Executive July 2011 – April 2013

Assisted in compilation of reports on spreadsheets and necessary documentation as needed to support regulatory department for regulatory filing, preparation of APQR and annual update

Actively developed procedures and work instructions for compliance activities such as change control, Out of Specifications, review of protocols/validations.

Assisted the Manager of Compliance in root cause analysis investigations and documented the compilation of findings.

Held the responsibility to ensure all shop floor activities are in cGMP compliance, reviewed all controlled documents such as batch records, standard operating procedures, labels, calibration documents and audit plans for engineering use.

Made sure that external controlled documents are submitted in timely manner and recorded, and successfully resolved circulation of expired labels and documents by issuing lot number

Implemented batch production record attachment checklist, to facilitate effective GXP adherence in accordance to regulatory specifications for batch record and log book attachments of the manufactured product

PROFESSIONAL ORGANIZATIONS & ACTIVITIES

Diploma in communication skills

Diploma behavioral sciences

I have actively participated in several academic seminars, as well as paper presentations in college and university-level competitions

SKILLS:

Proficient in MS-Office applications, tables and other data management tools

Excellent interpersonal and writing skills

Excellent team player, excellent organizational skills, highly detail oriented and a quick learner

Sound knowledge of IRB functioning, ICH guidelines, FDA regulations, HIPPA, CAPA, IND, NDA, ANDA, 510k, PMA, IDE, HDE submissions, document writing and submissions

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