SANJAY KUMAR GHOSH

Mobile: +91-953*******, +91-635*******, +91-983*******

E-Mail: addof8@r.postjobfree.com, addof8@r.postjobfree.com

Seeking assignments in Microbiology with an organization of high repute, preferably in MNCs in Pharmaceutical Sector.

Location Preference: Metro Cities

SYNOPSIS

M.Sc. (Microbiology) with nearly 12 years of experience in injectables

QC (Microbiology Department).

M.Sc. (Microbiology) with nearly 01 year of experience in injectable

IPQA Department.

Presently associated with Alembic Pharmaceuticals Ltd., Vadodara as Deputy Manager.

Adaptable and a quick learner; possesses skills to work under pressure.

Effective communicator with good interpersonal, analytical, management skills and ability to use them in productive manner.

CAREER SKETCH

Jan’18 with Alembic Pharmaceuticals Ltd., Vadodara as Deputy Manager

Key Responsibilities For IPQA:

To ensure that cGMP and GDP practices being followed with respective work area of facility.

To review SOPs, BMR, BPR and other Master documents of plant

To review the Cleaning validation, Process validation protocols and reports

To review validation related activities like Aseptic Process Simulation (Media Fill), Process Validation

To review of Risk Assessment of Equipment/Instrument and Process.

To be a part of cross functional team for investigation procedure for observation of Internal/External audits.

Responsible to carry out the In-process checks and Line clearance at different stages of batch manufacturing (Dispensing/Manufacturing/Filtration/Filling/Sealing/Visual inspection – as) and packing.

Responsible to collect the samples at different stages of batch manufacturing (In process/Finished) and packing (Control samples/Stability).

Ensure the compliance at shop floor by reviewing the equipment usage log books.

Responsible for the executed batch record review and batch release.

Responsible to carry out other assignments delegated or in absence of Head from time to time based on qualification, experience and training.

Key Responsibilities For IPQA (Microbiology):

Incident Investigation.

Deviation (Viz: SOP Deviation, New Intervention of Media Fill etc.) Investigation

QMS activities (CAPA, Change control)

Team management for performing the daily activities related to IPQA (viz: Line Clearance, Environmental monitoring activities, In-process sampling, Cleaning Verification and Cleaning Validation sampling activities)

Review of the Documents viz: SOP, BMR, CFT Investigation Reports etc.

Handling of Visual Inspection activities related to 07 days and 14 days incubation During Media Fill.

Key Responsibilities in QC Microbiology:

Incident Investigation.

QMS activities (CAPA, Change control)

Lab compliance (Independent Review of any Document for the Microbiology Laboratory),

Group Leader for media management, Method Validation and Disinfectant Efficacy Test.

Apr’16 to Jan’18 with Dr. Reddy’s Laboratories Ltd., Visakapatnam as Asst. Manager

Key Responsibilities:

Incident Investigation (Site Investigation Team).

QMS activities (CAPA, Change control)

Review of BET documents

Lab compliance (Independent Review of any Document for the Microbiology Laboratory),

Training Compliance

Audits gone through:

USFDA:01

ANVISA: 01

Romania:01

Feb’13 to Mar’16 with Aurobindo Pharma Ltd., Hyderabad as Senior Executive

Key Responsibilities:

Analysis of raw material, in-process and finished products & stability samples for variety of Microbiological Limit Tests, PET.

BET of products and water.

Audits gone through:

Name of the Audit

USFDA :01

FIMEA :01

UGANDA :01

Ukraine :01

Gulf :01

ANVISA: 01

Aug’09 to Jan’13 with CIPLA Ltd. as Microbiologist

Key Responsibilities:

Analysis of raw material, in-process and finished products & stability samples for variety of Microbiological Limit Tests.

Executing & performing Water Analysis, BET, Culture Dilution, PET, DET Environment Monitoring, GPT, Culture Enrichment and Media Preparation, Ampoule spore count of Geobacillius sterothermophillius. BIs testing, Surface challenge test with disinfectants.

Maintaining & validating microbial cultures and conducting validation of media & newly introduced methods.

Notable Highlights:

Efficiently performed Time Study for swab samples.

Distinction of completing the one Time Study of media suitability for environmental monitoring & one Time Study of time interval between sanitization and environmental monitoring.

Oct’07 to Jul’09 with M/s ResSancta (Pharma Unit) Belideor, Nalagarh (HP) as Officer Q.C

Key Responsibilities:

Involved in conducting chemical Analysis Syrups, water and raw materials such as flavours.

Responsible for sampling and analysis of raw material, in-process and finished products & stability samples for variety of Microbiological Limit Tests.

Notable Highlights:

Successfully prepared MLT Methods for raw materials and finished products.

Efficiently handled instruments & lab accessories like:

-U.V. Spectrophotometer (Shimadzu- UV 1700)

- Refracterometer (Sharthak)

- Polarimeter (Sharthak)

- pH Meter (Lab India – Phan)

- pH & Conductivity Meter (Lab India- Phan)

- Analytical Weighing Balance

- Vacuum Oven

- Hot Air Oven, etc.

Aug’06 to Sep’07 with M/sBakson Drugs & Pharmaceuticals Pvt. Ltd. (HP) as Trainee Officer Q.C

Involved in conducting chemical Analysis Syrups, water and raw materials such as flavours.

Responsible for sampling and analysis of raw material, in-process and finished products for variety of Microbiological Limit Tests according to Homeo pharmacopeia of India.

INDUSTRIAL TRAINING

Organization : Peerless Hospital (B.K Roy Research Institute), KOLKATA

Duration : 1 month

Project Title : WIDAL Test

Description : Detection of antibodies in the serum collected from the people of Kolkata against the Salmonella spp. obtained from Denmark'.

THESIS

Thesis Title : Effect of Different Temperature, pH & NaCl Concentration on the Growth of Listeria monocytogenes (M.Sc.)

Description : Effect of above mentioned factors are still undefined in the research so the whole thesis is about

the determination of all these factors on this particular species & calculating their generation time.

SCHOLASTICS

M.Sc. (Microbiology) from Allahabad Agricultural Institute - Deemed University, Allahabad U.P in 2006 with 8.64/10 CGPA.

B.Sc. (Botany, Chemistry and Microbiology) from Dr. Babashaeb Ambedkar Maradwada University, Maharashtra in 2003 with 61.03%.

Intermediate (12th) with 58.6% in the year 2000.

High School (10th) with 59.6% in the year 1998.

IT FORTE: C language, MS Office & Windows 98/XP.

SEMINARS

Attended seminars on “Sustainable Environment” at Govt. College of Arts & Science, Aurangabad, Maharashtra.

Presented seminar on “Diagnosis of Salmonella spp. by WIDAL Test” at Allahabad Agricultural Institute- Deemed University, Allahabad.

Presented seminar on “Micro Biota of Vegetables” at Allahabad Agricultural Institute- Deemed University.

OTHER ACCOLADES

Served as College House Captain.

Functioned as member of College Cricket Team.

PERSONAL DOSSIER

Date of Birth : 16th April, 1984

Language Known : English, Hindi & Bengali.

Address : House No. : 70 - A / 13, North Lokpur, Naini, Allahabad-211008, Uttar Pradesh.

Present CTC – 1402250 Rs

Expected CTC- 30% or as per company rule.

Notice Period - 3 month

Incident Investigation

Team Management

Compliance

Training Compliance

Contact this candidate