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Change Control Chemical Engineering

Location:
Mumbai, Maharashtra, India
Salary:
5lahks per annum.
Posted:
November 17, 2023

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Resume:

EDUCATION

B. Tech Chemical Engineering

(**** to 2019) with 67.00 %

Adhiyamaan College of Engineering, Hosur.

Higher Secondary (2013 to 2015)

Sri Vinayaga Higher Secondary, Porasapalayam, Namakkal. Secondary School Leaving Certificate

(2012 to 2013) with 88.00%

WORK EXPERIENCE

PRAKASH

SUNDARAM

Executive

SUMMARY

Experienced Professional with B. Tech

degree, Hopeful for a Quality

Management Position in Bio-

Pharmaceutical Company Where I

Can Use My Skills to Work Towards

the Organizational Goal.

CAREER OBJECTIVE

To join a dynamic organization and bean

indispensable asset organization,

where I can build my career through my

abilities and prove myself an energetic,

enthusiastic and career- oriented

person under any circumstances where

my knowledge and hard work are highly

valued, respected and appreciated.

Intas Pharmaceuticals Ahmedabad (Executive)

May-2022 - Present

Vita Life Laboratories of Arch Pharma- Delhi

(Chemist) March 2021 - April 2022.

Zydus Takeda Healthcare Private Limited

(Production) 2019 - 2020.

SKILLS

HANDLING OF DOCUMENTATION

Issuance and review of BMRs, SOPs, Specification and all other quality related documentation in Q-edge QMS.

Review and acceptance of Change control and Coordinate with Cross-Functional team Assessment.

Support in Investigation with CFT For market Compliant and Recall of Product.

Follow up and closer of Change Control and Its Action Items.

Review tracking and closing of CAPA with effectiveness check.

Compilation of trends of APQR, CAPA, Change Control and Market Complaints.

Review and Release Batch in SAP MM Module.

Review of Deviation, Change Control and Quality Related Protocol and Reports in QMS documentation.

Review of EBMR and tracking & maintaining of Data Governance.

HANDLING OF SHOP FLOOR ACTIVITY

Experienced in Monitoring for IPQA activity.

Highly Skilled in Batch Manufacturing Related Activity with ALCOA and ALCOA PLUS Principles.

Support of IPQA activity such as Area clearance, Vial Issuance, IB issuance, Reconciliation and Dispatch activities with monitoring of GMP and cGMP activity.

-

CONTACT

PHONE:

978-***-****, 866-***-****

LinkedIn:

https://www.linkedin.com/in/praka

sh-sundaram-241570175

EMAIL:

ad070n@r.postjobfree.com

CURRENT LOCATION:

Ahmedabad

SOFTWARE / SYSTEM SKILLS

Q-edge QMS (Sarjen System).

DocPro for archival of quality documents.

SAP MM (MB51, QA32, QA33, MMBE, CV04N,

CV01N, CVO2N, for display CV03N, QM03).

LIMS (Laboratory Information Management

System) For Review of QC result & Stability

Data.

TMS for training.

ProcessXE

(LTS)Location Tracking System for RM/CM

material.

STRENGTHS

Self-motivated & Hardworking.

Quick Learner.

Communication skills and Leadership Qualities.

Flexible towards any Environment.

HOBBIES

listening music.

Hiking, Trekking.

Learning new things.

LANGUAGES KNOWN

Tamil

English

Hindi

Marathi

Telugu



Contact this candidate