NILAM PATEL

Chikhli (Rumla-moti koliwad)

Dist-Navsari,

Pin code-396060

Gujarat, India.

Tel : +91-769*******

Email : adbzdk@r.postjobfree.com

adbzdk@r.postjobfree.com

OBJECTIVE:

Currently seeking a suitable post that will provide me the opportunity to utilize my experiences on various responsibilities and challenges in the field of Quality Assurance in pharmaceutical organization.

PROFESSIONAL SYNOPSIS:

●Passionate and skilled personnel, currently fronting as ‘‘Officer QA’’ in Validation Section of Quality Assurance Department in Sovereign Pharma Pvt. Ltd. from May 2015 to till date.

●(Total Experience:4 years & 3 months).

●Furnished with knowledge of various manufacturing and packaging Equipment Qualification, Process Validation of Parenteral monitoring of Calibration of critical instruments.

●Furnished with knowledge of handling quality management system i.e. Change Control, Deviation, Risk Assessment and compliance to internal / external audits.

●Validation activities i.e. HVAC/ LAF’s, Autoclave, Ampoule / Vial Washing machine, Depyrogenation tunnel, Filling machine, Blister pack machines, Inspection machines, Microbiological incubators, Stability chambers, Deep freezer, Water system, Area qualification.

●Faced MHRA/Ukraine/Ethiopia/Cofepris-Mexico/WHO-India/ Belarus/ Loan License Party Auditors in second line and direct dealing with auditors in facility audits to Validation section.

●Ability in planning of work, resource management, co-ordination with other departments, compilation & presentation of data. Ability to communicate for services from outsourced laboratories and firms.

SUMMARY OF SKILLS:

Ability to teamwork, work independently, multitask and work in a fast paced environment

Excellent presentation and communication and working language abilities in English, Hindi and Gujarati.

Ambitious, hardworking and committed to deadlines and schedules.

Excellent critical thinking and problem solving skills.

Attention to detail and the ability to prioritize and effectively manage multiple tasks.

WORK EXPERIENCE:

Sr. No.

Name of Organization

Tenure

Designation

1.

Sovereign Pharma Pvt. Ltd., India

www.sovereignpharma.net

MAY’ 2015 – Till date

Officer

Quality Assurance

PROFESSIONAL EXPERIENCE:

●Quality Assurance – [Parenterals]

Experienced professional for execution of Qualification and Validation of major and minor equipment and processes.

Responsible for designing Validation Master Plan (VMP) and execution of qualification and validation as per VMP.

Hands on performing qualification of HVAC system linked to Online BMS (Building Management System), Depyrogenation Tunnel, Ampoule / Vial washing machines and steam sterilizers (components and terminal products)

Preparation of documents and execution of qualification of newly procured equipment.

Preparation of Validation / Qualification / Requalification / Revalidation/ Study Protocols and Reports for various equipment and processes after major modifications (Internal Projects handling).

Temperature mapping of rooms, incubators, coolers and stability chambers.

Calibration of instruments.

Handling of quality management system such as Change control, Events and Deviations.

Carrying out non-viable particle counts in different grade areas.

Preparation of SOP’s.

Allocate work to subordinates. Taking continuous follow up’s and status related to the work assigned and reporting summarized report to immediate boss.

●Key Contributions and Achievements:

Successfully contributed and actively participated as subject matter expert in second line member during Regulatory audit (MHRA).

Key personnel member to face various audits from contract givers and regulatory audits such as WHO-cGMP, WHO Geneva, COFEPRIS (Mexico), Ethiopian MOH and various other MOH’s.

Updating planners of validation and calibration according to execution and maintaining the status.

●Project undertaken:-

Handled project level Qualification activities for Small Volume Parenteral manufacturing facility at Sovereign Pharma Pvt Ltd, Nani Daman includes:

●Equipment Steam Sterilizer, Terminal Steam Sterilizer

●Lyophilizer.

●HVAC system, DPB, LAF.

●Ampoule Labelling Machines

●Instrumentation Skills:

Data Logger (Wired and Wireless) for mapping, Anemometer, Aerosol Photometer, Smoke Generator, Air Borne Particle Counter [Met One & PMS].

●Software:

Microsoft Office (Word, Excel, Power point), Adobe reader, Foxit PDF editor.

Citation of references on Internet as well as Guidelines.

●EDUCATIONAL INFORMATION:

Year / Duration

University / School

Education

Oct’ 2012 to Oct’ 2014

Rajiv Gandhi University of Health Sciences, Bangalore

M.Pharm (Pharmaceutics)

Aug’ 2008 to Aug’ 2012

B.Pharm.

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