Qa Officer.. Expertise in product quality review and QMS section

MANUNI R. PATEL

Address: Contact Details:

***, ****** *********, ************@*****.***

Kachigam Road, +91-992*******

Beside Saibaba Temple, +91-738*******

Vapi, 396 191

Gujarat, India.

• OBJECTIVE:

A career that suits my ambitions for achievements through hard work and that, which can best utilize my analytical skills for the development of the organization and self.

• EDUCATIONAL BACKGROUND:

Sr

No.

Qualification

Board/

University

Passing Month &

Year

Percentage

1.

M. Pharm

G.T.U

JUNE 2016

7.54 CGPA

2.

B. Pharm

G.T.U

JUNE 2014

7.47 CGPA

3.

H.S.C

G.S.E.B

MARCH 2010

52.80%

4.

S.S.C

G.S.E.B

MARCH 2008

77.54%

• PROFESSIONAL EXPERIENCE:

• Worked With Wockhardt Pharma Ltd Daman (Bhimpore) since July, 2016 To July 2017 In QA Department and IPQA as an Apprentice.

• Alkem Laboratoried Limited, Amaliya, Daman from 22 July 2017 to till date as a senior officer in QA department in QMS section.

• PREVIOUS EXPERIENCE JOB PROFILE:

• Good knowledge about manufacturing equipment.

• Verification of dispense material i.e. Sifting of API & EXCIPIENTS.

• Daily verification and calibration of weighing balance and maintaining their relevant logbooks.

• Handling Stability Samples & Control Samples.

• Responsible for line clearance during the Batch manufacturing and Packing.

• IPQA checks, line clearance, sample collections, in process checks at manufacturing and packing stage as per master record.

• Issuance, Retrieval and control of documents like BMR, BPR, SOP’s, and Loose Formats, Log books.

• Involved in Control sample management.

• To ensure the retention and destruction of GMP documents and records as per SOP and to maintain the list of master documents like BMR, BPR, SOPs etc.

• To ensure online documentation on Shop Floor by reviewing all relevant documents and records.

• Involved in Annual Product Quality review data entry.

• PRESENT COMPANY PROFILE:

Presently working with Alkem Laboratories Ltd, Amaliya Daman from 22 July 2017 to till date as a Senior Officer in Quality Assurance Department.

• CURRENT JOB RESPONCIBILITY:

• As a Deviation, Market complaint and investigation coordinator.

• Handling of deviation & Market complaint related investigations.

• Preparation and review of investigation reports related to deviations & Complaints.

• Timely log the deviations, complaints and make communication to initiate the investigation activities.

• Periodic monitoring of deviations, market complaint and investigation status to assess the need for expediting investigation

• Timely closure of deviation, market complaint and its investigation.

• To send the quality management notification related to Deviation and complaint.

• Preparation and review of Annual Product Quality Review (APQR) and & Continuous Process Verification handling.

• Establishment of OOT limit by using Minitab software.

• Handling of Technical agreement w.r.t manufacturing as well contractual agreement.

• Effectiveness verification of Audit compliance.

• Preparation of compliance report of Self inspection and other regulatory compliance.

• CAPA handling & Responsible for checking CAPA effectiveness.

• Control sample Handling (storage, visual inspection & its yearly Destruction).

• Preparation, review of Standard Operating Procedure.

• Handling of change controls related activities like initiation, evaluation and activity completion of the change control.

• Preparation and review of Validation protocol and reports.

• MAJOR ACHIEVEMENTS & AUDIT EXPERIENCES:

• Audit exposure of USFDA, BfArM Germany, and MCC & ANVISA audit for QMS related activities.

• Good knowledge about DMS (For SOP, specification), TMS (training management system) & LIMS system

• Good knowledge about Trackwise system.

• Good knowledge about the Minitab software used for statistical calculation.

• STRENGTHS:

• Fluent in spoken & written English, Gujarati & Hindi.

• Effective communication & friendly nature

• Good Practical Knowledge.

• Positive Approach, sincere, hardworking, punctual, discipline with a good sense of humor.

• Hold strong ability to handle multiple priorities and prioritize workload.

• Ability to work on own initiative and as part of a team.

• Ability to work under deadlines.

• PERSONAL PROFILE:

NAME: Manuni Ruchitkumar Patel

DATE OF BIRTH: 19 Nov 1992

AGE: 29

MARITAL STATUS: Married

MOTHER TONGUE: Gujarati

HOBBIES: Listing music, Travelling

UNDERSTAND: English, Hindi and Gujarati.

• DECLARATION:

I, Manuni Patel, hereby declare that the information contained herein is true and correct to the best of my knowledge and belief.

(MANUNI PATEL)

Place: Vapi

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