Job Objective

Grow with a leading organisation that utilizes my abilities to the fullest extent possible, helping me realize and develop my potential and be a part of a team that scales great heights.

Profile Snapshot

Bachelor of Pharmacy with Approximately 14.0+ years of experience in:

Manufacturing Operation Process Improvement Material Management

Troubleshooting Documentation Team Management

Working with,Reliance Life Science Pvt. Ltd.Navi Mumbai as Deputy Manager–Plasma Protein sterile Manufacturing and filling.

Manufacturing documentation expertise & proficient with relevant industry standards.

An effective communicator with good time management and problem solving skills.

Employment History and Job Profile

Current Employment

Reliance Life Science Pvt. Ltd.Navi Mumbai, Maharashtra,India

Apr 2018-Till Date: Deputy Manager–Production

Apr 2013-Mar 2018: Senior Executive-Production

Jan 2012-Mar 2013: Executive-Production

Efficiently handled plasma protein upstream and downstream processing.

Involved in plasma protein new plant setup, installation and qualification process.

Leading a team of people for achieving the monthly target in production .

Preparation of SOP’s, protocols, IOQ documents.

Preparation of E-BMR in PAS-X Werum.

Actively participated in Autoclave validation, De-pyrogenation tunnel and process simulation.

Handling the consumables procurement for the department.

Handling of Audits and its compliance as per the regulatory requirements.

• Coordinating with various department for ensuring accomplishment of production targets.

Maintaining documents of Manufacturing operations, Audits, BMR’s, SOP’s Standards.

Actively participated in Autoclave validation, De-pyrogenation tunnel and Filling validation.

Actively participated in Media fill activities.

Involved in the SAP entries and material management.

Incident and CAPA management through QMS(Trackwise).

Preparation and review of SOP’s,change control through DMS (PharmaReady).

Responsible for carrying out regular GMP inspection and point out the anomalies and corrective actions.

Competent Technical staff certification from FDA.

Past Employment

Zydus Cadila Limited, Ponda, Goa, India

Aug 2010-Jan 2012: Production Executive

KEY PERFORMANCE AREA

Manufacturing and Filling of various products like Theophilyyin and Etophyllin, Hyoscine butyl-

Bromide, Ramosterone hydrochloride. Diclofenac sodium, Uromitexan, Citocolin etc.

Filling of various Extra Contrast Media products like Tirofiban, Meglumine Amidotrizoate,

Sodium Amidotrizoate and Meglumine Amidotrizoate, which manufactured for Emcure Pharmaceuticals.

Filling of various Hormone product like Testosterone, hydroxyprogesteronecaproate,Progesterone, nandrolone-phenylpropionate etc. which are manufactured for Shering-Plough and MSD.

Leading a team of people for achieving the monthly target as per plan with safety and quality.

• Coordinating with various department for ensuring accomplishment of production targets.

Maintaining documents of Manufacturing operations, Audits, BMR’s, SOP’s Standards.

Actively participated in Autoclave validation, De-pyrogenation tunnel and Filling validation.

Actively participated in Media fill activities.

Involved in the SAP entries, change control, Incident, QMS.

Preparation of SOP’s.

Responsible for carrying out regular GMP inspection and point out the anomalies and corrective actions.

Merck Limited, Ponda, Goa, India

Sep 2008-Aug 2010: Jr.Officer -Production

KEY PERFORMANCE AREA

• Leading a team of people for achieving the monthly target as per plan with safety and quality in production and packaging.

Maintaining documents of Manufacturing operations, Audits, BMRs and BPRs, SOP’s Standards.

Actively participated in Autoclave validation, De-pyrogenation tunnel validation,filling machine validation,AIM validation.

Actively participated in Media fill activities.

Handling of Utility support systems and it’s sanitization like ROEDI,PW,WFI and PSG plant.

Handling the Preparation and review of SOP’s.

Responsible for carrying out regular GMP inspection and point out the anomalies and corrective actions.

Responsible for training of department staff, workmen and maintaining the training documents.

Preparation of qualification protocol.

Preparation of monthly production plan for proper resource utilization and productivity.

Inventory management of consumables used in department.

Equipment Handled

Sr. No.

Equipment name

Make

1.

Ampoule washing machine

Petal, Kambert, BOSCH, Romaco

2.

Vial washing machine

Petal, Hari Krishna, Laxmi industries,Truking, Romaco

3.

De-pyrogenation tunnel

Klenzaid, Petals, BOSCH, Romaco

4.

Ampoule Filling Machine

Petals, Kambert,BOSCH,Romaco

5.

Vial Filling machine

Petals, Laxmi, BOSCH, Truking, Romaco

6.

Autoclave (Steam sterilizer)

Pharmalab, Machine Fabric, Fedegari, ICOS, sterdill

7.

Dry Heat Sterilizer

Pharmalab

8.

Manufacturing Vessel

Pharmalab, Adams, National.

9.

Integrity Testing Machine

Millipore, Sartorius, Pall

10.

Ampoule& vial inspection machine

ESAI, Sedeinader

11.

Lyophilizer

Edwards, Truking,SP Industries

12.

Lable printing machine

Akash

13.

Packing machine

Pharmpack,Select,Precision gear

14.

ROEDI,WFI,PSG system

Pharmalab

15.

Chromatography system

Millipore, GE

16.

Ultra filtration system

Millipore, Sartorius

17.

Centrifuge

Pennwalt, GEA Westfalia

Audit Exposure

CDSCO, WHO, Ukraine

Academic Profile

Bachelor of Pharmacy from Modern College of Pharmacy,Pune,Maharashtra (2008).

H.S.C from SMV college, Pune,Maharashtra(2002).

S.S.C from Guru ganesh vidhyalaya,Pune,Maharashtra (2000).

Additional Certificates

Microsoft Office, Access and Internet Application.

Personal Details

Name: Prashant Prakash Sawant.

Date of Birth: 12thMarch 1984

Permanent Address: Room no. 01, Sanjivani niwas, Vitthalwadi,Akurdi, Pune,Maharashtra 411035

Present Address: Flat no.104, Sai Darshan Appartment,P&T colony, Nandivli Panchanand, Dombivli,

Maharashtra 421201

Languages Known: English, Hindi, Marathi and Konkani

Declaration

I hereby declare that all the information given is true and complete to the best of my knowledge and belief.

Place-Mumbai

Date-

Prashant Sawant.

Contact this candidate