» Lead Audito: Masters degree in Industrial Pharmaceutical Science Latest Jobs Openings in Companies in India
Name: Prashant Shirode
Objective
To obtain a management position with a stable and progressive organization that will allow me to utilize my education and skills, as well as providing me with career growth and promotional opportunities.
Qualifications
Worked in Quality Assurance area as Head – Quality Assurance for 7 years; Total 15 years Pharmaceutical Industrial experience along with 7 years hand-on experience in Production of tablets, capsules and liquid manufacturing. Worked as a Compliance Officer in Regulatory Affairs department, for more a year.
Education
2003-2005 Masters degree in Industrial Pharmaceutical Science from Royal College of Surgeons in Ireland and IT, Sligo, Ireland (for the attainment of Qualified Person status in European Member states as described in Article 51 of Directive 2001/83/EC).
1986-1991 Bachelor degree in Pharmacy in II Grade from Pune college of Pharmacy, Pune University, Pune
1991-1992 Diploma in Business management (part I) from Pune University in II Grade
Employment
04-2007… Quality Assurance Manager / Qualified Person in Neolab Ltd., Odiham, Hants RG29 1LF, United Kingdom
Responsible for batch disposition (product release) in national and international market sale, handling of customer complaints, monitoring and reviewing all documents to provide quality review for major investigations, existing dossiers and in-house quality system documents. Also responsible for total Quality Assurance activity including smooth product transfer within & outside the company, Supplier’s audit (API & finished product manufacturer including packaging site/s), Stability studies, Coordination for all Regulatory inspections by MHRA.
11-2005-04-2007 Qualified Person in Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, CO. Galway, Ireland
Responsible for batch disposition (product release) in national and international market sale, handling of customer complaints, monitoring and reviewing all documents to provide quality review for major investigations, existing dossiers and in-house quality system documents. Also responsible for total Quality Assurance activity including R&D Coordination, Validation, Product transfer within & outside the company, Supplier’s audit, Stability studies, Local FDA Coordination.
02-2004-11-2005 Regulatory Affairs Compliance Officer in Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, CO. Galway, Ireland
Responsible for monitoring and reviewing all the documents, to provide compliance review for major investigations, existing dossiers and in-house quality system documents.
05-2002-02-2004 Production Executive in Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, CO. Galway, Ireland. The promoted to Production Supervisor for Evening shift.
Responsible for day-to-day production activities, preventive maintenance, production planning, departmental documentation.
01-2002-04-2002 Manager – Quality Assurance in M/s Associated Capsules Ltd., Pune, India
Responsible for total Quality Assurance activity of manufacturing unit including Validation, Product transfer, Document updating, Supplier’s audit, ISO9001 Audit, Handling of customer complaints, Product releases for Local & Export sale, Local FDA Coordination.
12-1996-12-2001 Sr. Manager – Quality Assurance in M/s Nicholas Piramal India Ltd. (Formerly known as M/s Boehringer Mannheim India Ltd.) in Mahad, Dist. Raigad, India
Responsible for total Quality Assurance activity including R&D Coordination, Validation, Product transfer, Document updating, Supplier’s audit, Chief Coordinator for ISO9001 Certification, Handling of customer complaints, Product releases for Local & Export sale, Stability studies, Local FDA Coordination.
Joined as Manager GMP in 12-1996 and promoted as Manager QA in 1998. Since
04-2000, worked as Sr. Manager QA.
02-1992-12-1996 Production Executive in M/s Cipla Ltd., Mumbai Central, Patalganga & Pune, India.
Responsible for day-to-day production activities, preventive maintenance, production planning, departmental documentation.
10-1991-02-1992 Production Officer in M/s Emcure Pharmaceutical’s Ltd. In Pune, India
Responsible for day-to-day production activities in sterile powder-filling facility & ointment preparations area.
Professional Skills
Auditing skills – Attended “Lead Auditor” training program; Trained Internal auditor; worked as team leader for various audits like ISO 9001, WHO-GMP certification.
Supervisory and coordination skills – Approval to manufacture tablets and liquids from local FDA bodies, India.
I T – Sufficient knowledge about usage of various Microsoft Programs like Word, Excel & ERP module like MFG / PRO 7.4F; Usage of Group-ware communication program like Lotus Notes R5.
Achievements in Profession Exposure to set-up of New Production plant TWICE during total span of 15 years Industrial experience.
Completed ISO 9001 certification of manufacturing plant within 16 months & Re-Certification with Revised Standard (ISO 9001:2000) within 9 months after initiation of process.
Initiation and implementation for Product Quality Review system in 1997 in the manufacturing plant.
Independent handling of QA/QC activity in absence of QA/QC Manager for 6 months in 2006-2007.
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Pharmaceutical Jobs
Industry: Jobs by Subject
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Name: Prashant Shirode
Objective
To obtain a management position with a stable and progressive organization that will allow me to utilize my education and skills, as well as providing me with career growth and promotional opportunities.
Qualifications
Worked in Quality Assurance area as Head – Quality Assurance for 7 years; Total 15 years Pharmaceutical Industrial experience along with 7 years hand-on experience in Production of tablets, capsules and liquid manufacturing. Worked as a Compliance Officer in Regulatory Affairs department, for more a year.
Education
2003-2005 Masters degree in Industrial Pharmaceutical Science from
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Name: Dinkar Panchal
Summary:
I have completed B.E in Civil Engineering (CTM) in the year 2005 and M.E. in WRM in the year 2007. Presently I am working in Larsen & Toubro Ltd. as Senior Engineer.
Career Objective :
Seeking a challenging environment that encourages continuous learning and creativity, provides exposure to new ideas and stimulates personal and professional growth.
The basic focus is to build a career satisfying the curious and challenging necessities of the mind and not just to do a job. I would do best in the field of work where I would have to extrapolate my innate qualities.
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