Pharma Operations Leader with 10+ Years Experience

RESUME

SOMASEKHAR MUCHELI E. Mail: **************@*****.*** Mobile: 809-***-****.

OBJECTIVE

To pursue a challenging Career in pharma sector by utilizing and enhancing my skills and to work in an environment that provides me a challenging edge to sharpen my skills and contribute constructively to the organization.

PROFESSIONAL EXPERIENCE

S. No.

Name of the organization

Last Designation

Work duration

1.

Axxelent pharma sciences Pvt. Ltd.

Deputy Manager

August 2022 – Till date

2.

Aurobindo Pharma Limited

Senior Executive.

March 2020 to July 2022

3.

Gland Pharma Limited

Executive

April 2016 to March 2020

4.

Strides Shasun

Executive

July 2015 to March 2016

5.

Hetero labs ltd

Jr. Officer

January 2013 to July 2015

WORKS HANDLED:

1.Line Activities.

Ensure production activities at shop floor as per controlled procedure.

Involve in line clearance.

Monitoring of online documentation.

To ensure that all activities in the organization are carried out as per cGMP guidelines.

Responsible for periodic Calibration of equipment’s and maintenance of records.

Responsible for planning and execution of batches as per given schedule in given time to meet market requirement.

To ensure samples (stability, control, PO, etc.,) are collected as per sampling plan, AQL checks samples collected and checks done as per procedure for further batch process.

Coordination and communication with cross functional departments to reach the targets in specified time.

2.Documentation activities.

Preparation and review of Master Batch Records as per Master Formula card and as per serialization (For USA and Europe markets).

Preparation, review and approval of Master SOPs, Validation protocols.

Review of executed batch packing record, physical inspection of material during dispatch in packing areas and final release of batches.

Review of packaging art works.

3.QMS Activities.

Preparation, review of change controls, deviation, market complaints.

Perform the assessments or cross functional team change controls (facility change controls, process / document change controls, etc.,)

Preparation, review and approval of investigation reports related to deviation, market complaints, validations.

4.Qualification and Validation activities.

Responsible for equipment qualifications of both primary and secondary packaging processes including computer system validations.

Involved in aseptic process simulation studies.

Responsible for Qualification and requalification of visual inspectors for manual inspection of parenteral products.

Responsible for execution of equipment validation protocols including serialization.

5.Miscellaneous

Control and training to manpower and newly joined employee.

To conduct on the job training to all the newly joined Employees and refreshment training to Existing Employees.

Involve in budget allocation for manpower, consumables, product process requirement and recruit of persons required to perform the activities.

PROFESSIONAL STRENGTHS

Handling of deviations / incidents.

Handling of change controls.

Handling of equipment validation and revalidation.

Handling of investigation for market complaints.

Preparation and review of standard operating procedures.

Preparation and review of Master Batch packing records as per serialization requirement.

PERSONAL SKILLS

Willingness to learn new ideas.

High degree of initiative and Strong Motivation power.

Strong verbal and written communication skills.

Excellent analytical and troubleshooting skills.

Comprehensive Problem Solving and decision-making capability.

PROFESSIONAL SKILLS

Good inter personal skills and as a team member work effectively with global and virtual teams.

Able to manage multiple priorities successfully.

Strong presentation and public speaking skills.

Can successfully complete targets as per pre defined schedules.

Professional attitude towards hard working.

TECHNICAL SKILLS

Ms Office and basic internet applications.

MACHINES HANDLED

Automatic filling machines Snowbell

Combi ampoule vial filling line – Washing machine, de-pyrogenation tunnel, filling machine, capping and sealing machine.

Combi PFS and cartridge filling machine.

Ophthalmic machine.

Brief knowledge on Manufacturing vessels – Pharma tech

Brief knowledge on Auto claves including terminal sterilizers – Pharma lab.

Brief knowledge on Automatic inspection Machines

X-ray inspection machine (Lyophilized product inspection),

Automatic vial (liquid filled) inspection machine (BREVITTE CEA).

Auto check weigher (Technofor)

Weighing ophthalmic bottles, Packed cartons

Labelling Machines –

Automatic plunger rod fixing, preventis assembling and labeling machines CORIMA Machine, Snowbell PRILM machine for Prefilled syringes.

Maharshi labelling machine for labelling Vials, ampoules, ophthalmic boles.

NKP technologies - for labelling Vials

Blister Packing Machines –

Integrated Blister Packing Machine (CAM) with auto-cartonator and Jekson camera inspection system.

BQS-Pam-Pac with ACG inspection system and Jekson camera inspection system.

Hoonga.

ACG- BP450AD with ACG inspection system

Knowledge on serialization equipment Jekson-Track and trace machine including PCR, OPTEL Machine, ACG machine.

Auto-Cartonator machine-Pam-Pac with ACG inspection system.

Knowledge about bulk packing machines CVC, Pharma-Pack bulk packing machines Unscrambler, tablet counting machine, Sachet inserter, cotton inserter, rotary screw capping machine, induction sealer, re-torquer, labelling machine, Outserter machine.

ACCOMPLISHMENTS

Preparation and coordination in many successful regulatory audits including USFDA,ANVISA, PFIZER, Dr. Reddys, Uganda, Mexico-Sandoz, Novartis, INVIMA, Bluefish, GSK, etc.,

EDUCATION

Master of pharmacy from Vision College of pharmaceutical sciences and research, JNTUH, Hyderabad, 2013-81.65%

Bachelor of pharmacy from Mallineni Lakshmaiah College of pharmacy singarayakonda, Acharya nagarjuna university-81.25%

Intermediate from Sri Chaitanya junior college, hyderabad-90.4%

10th class from Siddhartha high school, Hyderabad-82.5%

PERSONAL PROFILE

Name : SOMASEKHAR MUCHELI.

Fathers Name : Jaya chandraiah.

Gender : Male.

Date of Birth : 12-10-1987.

Marital Status : Married.

Nationality - Religion : Indian - Hindu

Address : Vallivedu (Village and post), Venkatagiri (Mandal), Tirupathi (Dist), Andhra Pradesh.

DECLARATION

I, SOMASEKHAR MUCHELI hereby declare that the above mentioned information is correct as per my knowledge and I bear the responsibility for the correctness of the above mentioned particulars.

Date: (SOMASEKHAR MUCHELI) Place:

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