P. SANJEEVI GIRI BABU
Summary
Diligent & result-oriented Quality Assurance Professional, B.Pharmacy with 15 years of
experience in Pharmaceutical industry in the area of Solid Dosage Form.
All-round competencies in Quality Assurance domain including all aspects covering –
Validations (Process validation, Cleaning validations and Equipment qualifications),
QMS and Manufacturing Assurance.
Qualification:
B a ch el orof Ph a r mac y
Fr m Ra gh a ven dr a In s ti tu te f Ph a r ma c eu tic a l Educ a ti on &
Re s e a rc h .
Overview
18
18
years of professional experience
Work History
Manager
Cronus Pharma Specialties Ltd
Hyderabad
05.2022 - Current
- Responsible for monitoring the Change controls, Deviations, CAPAs
- Responsible for monitoring the new product executions
- Responsible for review the BMRs
- Responsible for review the SOPs
- Responsible for trainings
- GAP assessment before introduction of new product in the facility
- Responsible to review change proposals for execution of process optimization and
- Process validation batches
- Review of Process optimization protocols and reports
- Review of Process Validation protocols and reports
- Review of Hold time study protocols and reports
- Review of Cleaning validation protocols and reports
- Responsible to review of exhibit batch BMRs/BPRs
- Responsible to preparation of responses related to regulatory and customer queries
- Responsible for raising the indents based on requirements.
Dy.Manager
MSN Labs
Hyderabad
03.2019 - 04.2022
- Manufacturing Assurance and Validations:
- Ensure the pre-requisites like Technology transfer documents, equipment and facility readiness to execute the new products
- Technology transfer documents verification and review
- GAP assessment before introduction of new product in the facility
- Responsible to review change proposals for execution of process optimization and
- Process validation batches
- Review and approval of Process optimization protocols and reports
- Review and approval of Process Validation protocols and reports
- Review and approval of Hold time study protocols and reports
- Review and approval of Cleaning validation protocols and reports
- Monitoring of commercial batches as a part of Continued Process Verification
- Responsible to review of exhibit batch BMRs/BPRs
- Responsible to arrange the documents to RA for regulatory submissions
- Responsible to preparation of responses related to regulatory and customer queries
- Responsible to review of SOPs.
Asst.Manager
PHARMA SPECIALITIES, LIMIED (Aurobindo Group of Companies) Shameerpet, Rangareddy
Hyderabad
08.2016 - 02.2019
- Manufacturing Assurance and Validations
- Ensuring cGMP (current Good Manufacturing Practices) and required SOPs to be followed during manufacturing of the drug product
- Ensure the pre requisites like documents, equipment and facility readiness to execute the new products (Exhibit batches)
- Performing internal audits
- Responsible to review of exhibit batch BMRs/BPRs, Process optimization, Process validation protocols and Hold time protocols and reports
- Responsible to review of URS documents
- Responsible to execute the FAT documents
- Responsible to review of qualification documents (IQ, OQ and PQ)
- Responsible to review of process optimization and Process validation change proposals
- Responsible to arrange the documents to RA for regulatory submissions
- Handling of deviations & change controls related to manufacturing assurance
- Review of manufacturing records.
Sr.Executive| Quality
Hyderabad
03.2014 - 12.2015
- RA Chem Pharma Finished Dosage
- Form, Equ i pme n t Qu a li f ic a tio n s
- Handling of equipment qualifications
- Responsible for review of equipment qualification protocols and reports
- Preparation, review and compilation of periodic revalidation protocols
- Responsible for reviewing SOP’s and PMP’s check lists related to equipment
- Handling of deviations & change controls related to qualification
- Pr
- C es s val i da tion s
- Responsible for review of process validation protocols & reports for all the products manufactured for various regulatory markets
- Responsible for review of hold time study protocols and reports
- Responsible for preparation and reviewing of SOPs
- Handling of deviations & change controls related to process validations
- Responsible to arrange the documents to RA for regulatory submissions
- Han dl i ng
- F I PQA ac ti vi tie s fo r Ma nu f a c tu r in g a re a
- Ensuring cGMP (current Good Manufacturing Practices) and required SOPs to be followed during manufacturing of the drug product
- Review of manufacturing records to assure that all in-process checks, reconciliation & entries are compliance with specification and regulation
- Performing internal audits
- Ensure no delays in dispatch of finished goods
- AUDITS FACED:
- USFDA, MHRA, COFEPRIS (Mexico GMP) Audits & Other Customer Audits.
Jr. Executive
NATCO Pharma Ltd
03.2008 - 07.2013
- Handling of IPQA activities for both Manufacturing & Packing area
- Ensure the cGMP compliance during manufacturing and packing stage
- Ensure that qualification is carried out as per protocol and qualification protocol meets the cGMP and regulatory requirements
- Review of BMRs
- Monitoring and implementing the sampling techniques for cytotoxic products in the isolators
- Having knowledge about isolators, Rapid transforming port / continuous liner port for handling of cytotoxic products
- Coordinator for handling of deviations, change control proposals and its investigations
- Involved in regular internal inspections
- Training to new officers and chemists regarding various operations, In-process checks, rules regarding cGMP and USFDA and daily documentations.
Chemist
NATCO Pharma Ltd
07.2006 - 02.2008
- Pre – formulation studies
- Formulation development trials
- Optimize the process
- Carry out the Process Validation studies
- Preparation Batch Manufacturing Records
- AUDITS FACED:
- USFDA, ANVISA, TGA & Other Customer Audits.
Skills
- Team Leadership
- Staff Management
- Issue and Conflict Resolution
- Cross-Functional Team Management
- Managing Multiple Tasks
- Timelines and Milestones
Work Preference
Work Type
Full TimeWork Location
On-SiteRemoteHybridTimeline
Manager
Cronus Pharma Specialties Ltd
05.2022 - Current
Dy.Manager
MSN Labs
03.2019 - 04.2022
Asst.Manager
PHARMA SPECIALITIES, LIMIED (Aurobindo Group of Companies) Shameerpet, Rangareddy
08.2016 - 02.2019
Sr.Executive| Quality
03.2014 - 12.2015
Jr. Executive
NATCO Pharma Ltd
03.2008 - 07.2013
Chemist
NATCO Pharma Ltd
07.2006 - 02.2008
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