QA Documentation specialist

USHA PURATCHIMANI ADDERSS FOR CORRESPONDANCE ***, Blossom Circle

Dayton,

New Jersey – 08810.

Visa status: EID Phone: 732-***-****

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

OBJECTIVE

I am in the pursuit of acquiring all the competencies for a complete career. Willing to work on challenging and critical tasks, which offers potential growth and development through the spirit of team work.

EXPERIENCE

From Apr. 2012-Feb-2015, working as a QA Associate in US Pharma Lab (USPL), New Jersey.

From Feb-2015 to now working as a QA Associate in Documentation at Aurohealth LLC, New Jersey.

Job Responsibilities

Review and approve specification, standard test procedure and analytical records of Raw material, In-process, Intermediate, finished product and stability.

Review of instrument / system qualification related documents in laboratory.

Preparation and review of SOP’s for QC, Manufacturing, QA, Warehouse. Batch Records and Packaging Records and other documents as required.

Responsible for Review and Approval of QC Documentation – Specifications, STP’s, GTP’s.

Responsible for generating code numbers as per ERP for Raw material, packaging material, documents, finished product, and semi-finished products.

Audit and ensure the IQ, OQ, and PQ of all equipment’s used in facility to manufacture the finished pharmaceutical products are completed in timely manner, with the relevant certificate, e.g. calibration, service report etc

To ensure that all inputs are analysed and released as per the specifications.

To ensure that awareness of cGMP requirements are evaluated and updated through periodic training and audits.

To ensure that the procedures in Quality Control and Manufacturing are carried out in accordance with Good Manufacturing practices.

To prepare the batch manufacturing and packaging records as per Product development and technical services group, according to current Good Manufacturing practices.

To ensure that the training of all personnel is carried out according to need & records maintained thereof.

To ensure self-inspections and quality audits are carried out as per schedule.

To ensure complaint handling and investigation with appropriate measures taken to prevent reoccurrence.

Responsible for releasing the Batch in to the market.

Implement the calibration procedure and schedule of all instruments.

Carry out preventive maintenance schedule for manufacturing equipments.

Monitor the chart Recorders.

Coordination for outside calibration.

Participate in the execution of Installation, Operational and Performance qualifications protocol for Engineering, Manufacturing and Packaging equipments.

Maintain the Equipment Qualification/Calibration Master List

Review the production batch record and packaging record

Maintain the confidentiality of the company operations, procedures and documents.

Perform any other duties as and when assigned by the management.

Responsible for assigning the code number to Batch manufacturing Record and Batch Packaging Record. To coordinate vendor qualification through audits, wherever necessary & evaluation of questionnaire. To obtain all required documents as part of qualification & update the vendor approval list as per specified frequency.

EDUCATIONAL QUALIFICATIONS

May 2004 B.E from Priyadarshini Engineering college, Vaniyambady, Tamilnadu, India.

Specialization – Electrical and Electronics Engineering.

With an aggregate of 78.93 %.

March 2000 (10+2) Board of Higher Secondary Examination from Govt. Higher Secondary

School, Puduppalayam, Rasipuram, Tamilnadu, India.

With an aggregate of 83.08 %.

April 1998 (10th) Board of Secondary Examination from Govt. Higher Secondary School,

Puduppalayam, Rasipuram, Tamilnadu, India.

With an aggregate of 84.6 %.

PERSONAL PROFILE

Date of Birth : 06.17.1983

Sex : Female

Nationality : Indian

Marital Status : Married

Languages known: Tamil, English and Telugu.

REFERENCES

Reference will be produced on request.

(USHA PURATCHIMANI)

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