Ankur Sharma
Email id : ankuscorpionk29 AT gmail.com
Objective
To add innovative ideas to work to achieve organization goal and to have continues self-development by way of learning and exposure to new assignment.
Total Professional Experience :-
Nine years and 06 Months
Present company profile :
Company :Glenmark Pharmaceuticals Ltd. V.P.O. Rajpura distt. Solan (H.P.)
Designation : Executive Q.A.
Experience : Nov. 2011 to till date.
Responsibilities :
** Preparation, data compilation and review of documents related to equipment qualification like URS, FAT, SAT, DQ, IQ, OQ & PQ of validation systems.
** Preparation, data compilation and review of documents related to Process Validation, Hold time study.
** Preparation of VMP or SMF as per schedule or regulatory requirement.
** Preparation, data compilation and review of HVAC system Qualification / Requalification protocol and reports.
** Preparation, data compilation and review of Compressed Air Qualification / Requalification protocol and reports
** Preparation and execution of Temperature mapping study protocols and reports..
** Preparation/ review of transportation validation related documents.
** Evaluation, review and ensuring the approval and implementation of Change Controls.
** Review of record related to instrument calibration and preventive maintenance of equipments.
** To perform validation activities as per schedule, cGMP & Audit compliance.
** To carry out in process checks as per respective batch production record in manufacturing, packing and warehouse.
** To ensure the manufacturing and packing operations are carried out as per the instructions given in the batch production record.
Responsibilities :
1.
Validation :
** Process Validation & Cleaning validation
** Preparation of Validation protocol and validation report.
** Compilation and maintain the validation record of analytical data.
2. Hold Time Study :
** Preparation of hold time study protocol and report
** Sampling of all intermediate stages as per schedule.
** To compile the hold time study report and maintain records.
3. Equipment qualification
4. Utility qualification
HVAC system, Air compressure
Audit Exposures :
** ANVISA
** WHO-GMP
** Uganda (NDA)
** Tanjania (TFDA)
** Philippines
** NAMIBIA
Academic Background :
** B.Pharmacy BIS College of pharmacy (P.T.U)
** 10+2 H.P.B.S.E. Dharamshala.
** 10 TH. H.P.B.S.E. Dharamshala.
Hobbies :
** Listening & singing the Music, Photography
** Badminton , cricket player
** Traveling
Personal Information :
Age : 32 yrs.
Date of Birth : 21.11.1988
Marital Status : Married
Language known : English, Hindi
Nationality : Indian
Personal strengths :-
** Firm believer in discipline and time management
** Having good organizational administrative and communicational skill.
** Positive attitude, honesty, hardworking, fast learner of new things
** Able to work independently with accuracy
Declaration :
I, hereby declare that all the information provided is true to the best of my knowledge and belief.
Place : Nalagarh
Date :