RESUME

GANESH BHAUSAHEB INGALE

Master of Pharmacy (Pharmaceutical Technology)
Mobile: +971501861384/+919763548994 E mail : ganesh.ingale16@gmail.com

OBJECTIVE
To obtain a Quality Assurance position in the field of Pharmaceutical, Biotechnology, Bio
pharmaceuticals where my academic credentials, Skills and Expertise can be utilized to the growth
and success of your organization.

SUMMARY
7.6 Years experience in Pharmaceutical and Bio pharmaceutical Quality Assurance department of
reputed organizations. Experience includes exposure to Quality Systems, validations as well as In-
process Quality assurance activities in different Sterile and Non sterile formulations.

ORAGANIZATIONAL EXPERIENCE
1) IPCA Ltd. Waluj MIDC, Maharashtra, India (Since April 2017).

About Company: One of the largest manufacturer of API in India. Aurangabad Site
approved by USFDA, KFDA.

Responsibilities:
A. Handling of Batch Release :- To comply with set quality management system and
standards while managing company goals which involves compliance of analytical report
and Batch record, To ensure closure of Deviation/Change control/OOS related to batch.
B. Handling of IPQA Team(6 members) , involves active participation in plant round
reporting and resolving non compliance by conducting meeting, discussing with Site
technical committee and raising the issue in best forum.
C. To perform investigations related to returned good, OOS batches.
D. Review of Technical documents such as Establishment report, APQR, Sops.

2) JULPHAR, Gulf Pharmaceutical Industries, Ras Al Khaimah, UAE(2 Years 1 Month)

About Company :- Largest drug manufacturer in MENA region. Julphar manufactures wide
range of Sterile/Non Sterile dosage forms at USFDA, SFDA approved facilities. It also have
Biotechnology facility for Recombinant Human Insulin manufacturing and formulation where i
have worked.

Responsibilities:
A. Complete responsibility of Quality Management Systems such as Change control,
Deviation, Risk assessment, Handling of market complaints, Product recall. This involves
logging, Investigation/Impact assessment, CA/PA tracking, Closure, Post implementation
reviews.(Compliance to WHO,ISO,MOH, MHRA, USFDA)
B. Handling of Internal Audit involves schedule preparation, conduction of audit, non
compliance CA/PA tracking and closure.
C. Review of documents such as SOPs, Technical documents
D. Supply chain validation(Shipping/Transport Validation).

3) MABPHARM Private limited, (Subsidiary of Cipla now Cipla Biotec), Verna, Goa, India (2 Years 8
Months)
 RESUME
GANESH BHAUSAHEB INGALE
Master of Pharmacy (Pharmaceutical Technology)
Mobile: +971501861384/+919763548994 E mail : ganesh.ingale16@gmail.com

About Company :- One of the leading generic manufacturer in India has remarkable global
presence. Involved in development and manufacturing of Biotech Product. I was working as a
formulation QA involved in manufacturing Biotech finished product (Sterile formulation).

Responsibilities:
A) Responsible for QA activities at Injectable manufacturing facility such as IPQA, Review of
batch Documents, To involve in Failure investigation,
B) Handling of QMS: - Change control, deviation, Risk assessment, Market complaint related
to formulation.
C) Certified Internal Auditor for Stores, IT and formulation department (ISO and WHO
compliance).
D) Part of Quality Management Review team. The task includes compilation of quality
management data, presenting to management and discussing the possible root cause for
repeated non-conformances.
E) To perform QA activities for Research and development of solid orals.

4) UNICHEM laboratories Limited, Goa, India (8 Months)

About Company :- Reputed manufacturer in India, products manufactured are marketed in US,
UK and other regulated markets. I was working in Solid Oral plant involved in manufacturing of
Tablets and Capsules.

Responsibilities:
A) Handling of market complaint:- To register compliant, Investigation and preparation of
investigation report.
B) Handling of Change control, Deviation, CAPA and Risk Assessment.
C) Review of BMR and BPR.
D) Handling of Audit (USFDA, MHRA)

5) CIPLA Ltd, Verna, India. (1 Year 9 Months)

About Company :- Aerosol (Metered Dose Inhaler) Manufacturing plant MHRA approved facility.

Responsibilities:
A. Member of IPQA team for Manufacturing and packing of Metered dose Inhalers
(Aerosols).
B. To carryout Process validation of metered dose inhalers.
C. To perform Quality Management Review.
D. Review of Batch manufacturing and packing records
E. Preparation for batch release.
F. To carryout unit operation review.
E. Quality In charge for shipping/Transport validation.

ADDITIONAL AREAS OF EXPOSURE

Audit exposure for USFDA, MHRA, MCA, Local FDA audits
Vendor audits
Handling of training
Manufacturing of Monoclonal Antibodies.
 RESUME
GANESH BHAUSAHEB INGALE
Master of Pharmacy (Pharmaceutical Technology)
Mobile: +971501861384/+919763548994 E mail : ganesh.ingale16@gmail.com

SEMINAR AND WORKSHOPS

Attended Seminar on Computer system validation organized by ISPE at Goa.

ACADEMIC QUALIFICATION
Masters of Pharmacy (Pharmaceutical Technology)
Registered Pharmacist (Registered Pharmacist under D&C Act 1948 India, State Maharashtra)

PERSONAL INFORMATION
Date of Birth: 27.02.1987
Nationality: Indian
Marital status: Married
Language Fluency: English, Hindi, Marathi
Leisure Activities: Reading
Alternate email Id: ganesh.detsiny@yahoo.co.in
Reference: Reference shall be provided upon request.

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