PRIYA SINGH PARIHAR

Profile A Quality professional with expertise in establishing Quality system of international standards (USFDA, MHRA, TGA) in pharmaceuticals, Biopharmaceutical and, Clinical Packaging and support services.

Since Oct 07 Fisher Clinical Services Ahmedabad, India

Sr Manager QA

Responsibilities:

• Ensuring that Business needs are met regarding Regulatory cGMP compliance (MHRA, EU, FDA) for Investigational Medicinal Product packaging and distribution worldwide.

• Manage Client Quality expectation.

• Quality system structuring and its implementation.

• Ensuring that Quality systems are in place and are effectively managed (CAPA, Deviations, Change Control, Complaints, SOPs, Audit program, Quality Investigation).

• Handling Local Administration for TrackWise System.

• Host and manage Client audits and lead the internal and third party inspection team.

• Validation master plan preparation. Manage the validation program to ensure compliance with Regulatory requirements.

• Support the GMP and GCP training activities for Fisher personnel.

• Manage the QA/QC team, allocating and controlling workflow.

• Monitor and review systems and processes with a view to support continuous improvement.

• Provide QA/QC support and input to the strategic development of the business.

• Production order review and Approvals

• Working on designing the Project requirement

• Qualification Protocol review and approvals

• Handling Quality and Technical Agreement for client

• COSHH Assessment of IMPs

• Regulatory approval for Packaging of IMPs.

• Communication with client QA for the required Quality Standards

• Handling Quality issues related to Distribution of Patient Kits.

Achievements:

• Client’s audits and approval

• MHRA approval for the facility.

Reward:

• Promoted form Manager QA to Sr Manager QA.

Apr 06 – Sep07 Zydus Hospira Oncology Pvt.Ltd Ahmedabad, India

Senior Executive Quality

Responsibilities:

• Preparation of SOP and Test Formats

• Preparation of validation protocol

• Plan for Environment Monitoring of clean rooms –Area Qualification

• Personnel Qualification

• Media fills Qualification

• Disinfectant Qualification

• Water System Qualification

• Execution of IQ/OQ/PQ protocol of Equipments

• Test method validation

• Trend analysis and its interpretation

• Handling of Deviations ,OOS and Change control

• Instruments handling and its calibration

• Listing and ordering of materials required for Quality control Lab

• Training personnel in Quality control and Manufacturing

• Documents control and review

• Work distribution and monitoring the implementation of SOPs

• Updating and training on new regulatory requirements

Jun’05 –Apr 06 Shreya Biotech Pvt.Ltd. Pune Maharastra

Growing Recombinant Biopharmaceutical company with a goal of USFDA.

Senior Executive Quality Control

Responsibilities:

• Setting up the Quality Control Laboratory

• Handling instrument purchase and documentation(URS,IQ,OQ,PQ)

• Listing and ordering the laboratory requirements

• Test method validation

• SOP, Protocol, specification and Format preparation.

• Instrument calibrations

Mar’02 –May’05 Claris Lifesciences Ltd. Ammedabad

A leading Paren tral preparation company and one of largest growing company in pharmaceuticals

Executive Quality Assurance (SinceMay’03)

• Promoted as executive QA from officer QC.

Achievements:

• Actively contributed to various international certification like MHRA, TGA , GCC, ISO,WHO, ENVISA, ENVIMA.

• Played a very crucial role in MHRA approval.

Responsibilities:

• In charge of microbiology department of QA.

• Handling a team of 8 people.

• Preparing and implementing SOP and validation protocols for microbiology department of QA.

• Allocation of work to the subordinates.

• Supervising and monitoring of the implemented processes.

• Preparation of validation plan.

• Routine monitoring of air, water and environment.

• Process, system and testing validation.

• Instrument (IQ, OQ, PQ) Calibration.

• Training of the new joiners.

Microbiologist QC (Mar’02-Apr’03)

Responsibilities:

• Routine testing of raw materials, packing materials and finished products.

• Testing includes:

Sterility Testing

Bacterial Endotoxin Test

Pyrogen Testing

Toxicity Testing

Bioburden Test

Liquid Particulate Test

• SOP and Test format preparation

• Test method validation

Jan ’02 –Mar’02 Gujarat Agricultural University Anand , Gujarat

Senior Research Fellow in ICAR Ad-hoc project.

Assessment and Characterization of heavy metal contamination in agricultural soils and plant in peri URBAN areas.

Sep’00- Dec’01 Biocare Research India Pvt.Ltd. Ahmedabad

Junior Scientific Officer

Responsibilities:

• Microbial Testing of pharmaceutical and dairy products

• Water, Cattle and Poultry feed testing.

• Clinical specimens testing

• Culturing and Susceptibility testing of various clinical specimens

Training • A two days training at LAB India, Delhi on Microseq rRNA.

• A two days training on Biological Indicators by Dr. P.K. Chitnis, Sales Worth India Pvt.Ltd, Bangalore.

• Dec 2006 attended Millipore workshop on “Advanced Microbial Methods in the Biopharmaceutical Industry-from Innovative Sampling to PAT Initiatives” in Pune. Scored first rank.

• Training on Clinical Packaging form Horsham UK.

Education 2007 Nov – 2008 Nov Institute of Clinical Research India (ICRI) Ahmedabad

• Post Graduate Diploma in Clinical Research

2004 Indian Institute of management studies Chennai, Tamil Nadu

• Diploma in QA &QS 9000/ISO 9000 71%

1998-2000 Gujarat University Ahmedabad ,Gujarat

• M.Sc in Microbiology 63%

1995-1998 Gujarat University Ahmedabad ,Gujarat

• B.Sc in Microbiology 65% Vocational Biotechnology

Personal Details Date of Birth: 21st April, 1977

Language: English, Hindi, Gujarati and Bhojpuri

Marital Status: Married

Sex: Female

Permanent Add:

D-404 Aryaman Awas,

Opp Sia Mandir, Near DebAshish School

Near Marriot Hotel

Ramdevnagar,

Ahmedabad-15

India

Phone no: 972-***-****, 909-***-****

E-Mail:fck9mk@r.postjobfree.com

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