Amneal Pharma Walk in Interview-1st December
(Sunday) OSD- INJ
We are looking for
competent, dynamic and motivated candidates for suitable positions for
Injectable & OSD (oral solid dosage) unit for our Ahmedabad SEZ Matoda
Plant.
Openings: 30
Date: 1st December, 2019 (Sunday)
Timing: 9:00 AM to 12:00 PM
Venue:
Amneal Pharmaceuticals Pvt. Ltd.
Plot No 15,16,17 Pharmez
Village: Matoda
Sarkhej Bavla Road, Ahmedabad
Timing: 9:00 AM to 12:00 PM
Venue:
Amneal Pharmaceuticals Pvt. Ltd.
Plot No 15,16,17 Pharmez
Village: Matoda
Sarkhej Bavla Road, Ahmedabad
Please find the Job details below:
OSD REQUIREMENT
1. Quality Control (QC - OSD)
Designation: Officer/ Sr. Officer/ Executive
Qualification: B.sc/ M.sc /B.Pharm /M.Pharm
Total experience: 02 to 07 years
1. Quality Control (QC - OSD)
Designation: Officer/ Sr. Officer/ Executive
Qualification: B.sc/ M.sc /B.Pharm /M.Pharm
Total experience: 02 to 07 years
Position: 20
Area: Technology Transfer, RM, FP, Stability, LIMS
Desired Profile:
Area: Technology Transfer, RM, FP, Stability, LIMS
Desired Profile:
1. Able to perform
sampling of raw-materials and packing materials within the specified time frame
to support manufacturing activities.
2. Should have
experience to perform analysis & documentation of Raw-materials,
In-process, Finished products, stability & validation samples by using
Caliber LIMS software
3. Exposure to for
management of working/reference standards on Caliber LIMS
4. Should have
exposure to perform analytical method transfer, method verification and method
validation activities as per ICH guideline and as per SOP's
5. Exposure to
prepare and standardization of volumetric solutions/reagents
6. Responsible to
perform all activities in laboratory in GLP compliance manner
7. Caliber LIMS
knowledge is preferable
INJECTABLE REQUIREMENT
1. Quality Assurance (IPQA) - Injectable unit
/Parenteral Unit)
Designation: Officer
Qualification: B.Pharm/M.sc Microbiologist
Total Experience: 01 to 03 years
Designation: Officer
Qualification: B.Pharm/M.sc Microbiologist
Total Experience: 01 to 03 years
Position: 5
1.
Responsible for preparation, review and
implementation of Standard Operating Procedures of Quality Assurance
department.
2.
Should have sound knowledge and
experience in Environmental Monitoring (Air Sampling, Settle Plate, Surface
Monitoring, Personnel Monitoring)
3.
Responsible for the review of BMR/BPR.
4.
Responsible for Document management like
BMR's, BPR's, Master SOP's, training records etc.
5.
Responsible for reserve sample
management, annual review and destruction as per Procedure.
6.
Responsible for tracking of stability
sample collection as per protocol.
7.
Responsible for stage wise line
clearance activity before commencing the operations like dispensing,
manufacturing, filling, Lyophilization, sealing, labelling and packing
operations.
8.
Supervision of sampling activity for in
process and finished samples for analysis and other samples requirement as per
protocols (Process Validation, Cleaning Validation etc.)
9.
Responsible to provide and fulfill the
documents requirement of regulatory affairs department for filing or other
requirements.
10. Activities other than defined
in the Job responsibility are to be done, as per the requirement of HOD, by
following HOD's instruction and guidance.
2. Quality Control - (Injectable unit
/Parenteral Unit)
Designation:
Officer/Sr. Officer/Executive
Qualification: B.sc/ M.sc/ B.Pharm/ M.Pharm
Total experience: 02 to 07 years
Qualification: B.sc/ M.sc/ B.Pharm/ M.Pharm
Total experience: 02 to 07 years
Position: 10
Area: GLP,
Calibration, QC QMS, LIMS, Stability
1.
Testing of raw material, packing
material, in-process, finished product and stability samples (as per stability
protocol).
2.
To keep neat and cleanliness at work
place and follow the Good laboratory practices in the laboratory.
3.
To keep update of instrument slog-books
and to record the data in LNB during testing. To attain and complete
self-training record.
4.
To initiate and review of A)Deviation
B)Out of specification/Out of trend C)Change control
5.
To ensure in and out of stability
samples from stability chambers.
6.
Charging of stability samples as per
stability protocol.
7.
To perform water analysis as per
specification, SOP and GTP.
8.
To co-ordinate QA for documentation for
issuance and retrievals.
9.
Review and monitoring of USP, EP, BP and
other pharmacopeia monographs for changes/ revision.
10. To prepare COA of various
product/material as per requirement whenever required.
11. LIMS master preparation for various
product / material/ instruments/ Volumetric solutions etc.
12. Registration of reference standard,
working standard, column, instrument etc. in LIMS
13. Preparation/updating of calibration
schedule in LIMS
14. Updating of LIMS master as and when
required
15. Preparation of configured Test plan.
16. Trouble shooting in LIMS, Involve in
Qualification of LIMS module/ Instrument, Preparation of LIMS related
protocol study and execution.
Department: QMS
Area: QMS - Deviation,
Vendor Qualification
Position: 2
Qualification: M.
Pharm
Experience: 3 to 6
Years
Job Description:
1. To handle
miscellaneous material and tertiary packaging material's vendor qualification
as per procedure.
2. To prepare and
update vendor list as per procedure and maintain vendor qualification
documents.
3. Review and
implementation of vendor notification/declaration provided by SSSM from
respective vendor at site.
4. To review
commercial artwork component and hand over to QA doc cell for distribution.
5. To handle the
contract agreement as per procedure
6. To review test
results comparison report of API/ Excipients against manufacturer's certificate
of analysis and Amneal's certificate of analysis for vendor qualification.
7. To maintain
regulatory commitment log.
8. To prepare and
review standard operating procedures of Quality Assurance Department.
9. Responsible for
document handling, issuance, distribution and retrieval of documents
10. Activities
other than that defined in the job description are to be done, as per the
requirements instruction / guidance of HOD.
11. To log the
change controls received from various departments.
12. To handle the
changes carried out in the location by assessing the risks associated with it
as per the change control procedure.
13. To prepare
standard operating procedures of Quality Assurance Department and review the
SOPs of cross functional departments.
14. To carry out
investigations to the deviations, market complaints, OOS, OOTs, etc. by using
appropriate root cause analysis tools, assessing the risk associated with them
and ensuring compliance of the non- conformance as per the cGMP by documenting
it through the CAPA system.
15. To conduct or
be a part of team conducting risk assessment of various activities, equipment,
systems, etc. in the location.
16. To analyse and
trend the deviations, market complaints and other non-conformance served in the
location to identify any repetitive observations for its further investigation,
risk assessment and CAPA.
17. Follow up with
various departments for completion of activities assigned in the change
control.
18. To review
updated guidelines and inform gaps in the current practices to respective
department heads and quality assurance head for its compliance.
19. Collection of
data required for preparation of management review report.
20. To co-ordinate
regulatory / customer audits conducted at the location, recording the day to
day activities, informing the same to the management, coordinate with
respective department for online compliance (if required) and provide the
compliance to the audit observations by coordinating with respective
departments and guidance of the HOD within the stipulated timeline.
21. Activities
other than that defined in the job responsibility are to be done as per the
requirements / instruction / guidance of HOD
Department: QA Document Cell
Position: 1
Experience: 2 to 6
Years
Qualification: B.
Pharm/ M. Pharm
Job Description:
1. To maintain
master documents like Site Master File, Validation master plan, Quality Manual,
SOP, Batch records, protocols, specifications, drawings, etc.
2. Responsible for
preparation, revision and review of standard operating procedure of QA department
and review the SOPs of cross functional departments.
3. To prepare and
maintain the Site master file and Quality manual.
4. Issuance of
approved Standard Formats and Log books to User Departments. To ensure that
only authorized formats are issued.
5. To receive the
product development documents like Master Formula Records, Master Packaging
records, protocols (sampling, study and stability protocols).
6. To co-ordinate
regulatory / customer audits conducted at the location, recording the day to
day activities informing the same to the management, coordinate with respective
department for online compliance (if required) and provide the compliance to
the audit observations by coordinating with respective departments and guidance
of the HOD within the stipulated timeline.
7. Activities other
than defined in the Job responsibility are to be done as per the requirement of
HOD by following HOD's instruction and guidance.
8. Responsible for
issuance archival and retrieval of documents like SOPs Validation / qualification
protocols / reports Batch records Specifications Drawings Artworks Approved
Vendor List Planner etc
9. Responsible for
verification of documents like Batch Manufacturing records Batch Packaging
Records Protocols SOPs Specifications etc.
10. To provide
requisite documents to regulatory affairs department for regulatory submission
whenever required.
The candidate with good communication and inter personal skills computer
knowledge and exposure to cGMP/ GLP Knowledge and understanding of regulatory
requirement is essential.
Note : Candidate should have 02 to 07 years of relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliance) organisation. You may walk in for interview with current CV along with CTC proof Appointment letter Increment letter & last 3 months salary slip & Bank statement Aadhar & PAN card and 2 passport size photograph.
If you are unable to attend interview you can share cv on chandanid@amnealindia.com, neha.modi@amnealindia.com, kishan.soni@amnealindia.com
Note : Candidate should have 02 to 07 years of relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliance) organisation. You may walk in for interview with current CV along with CTC proof Appointment letter Increment letter & last 3 months salary slip & Bank statement Aadhar & PAN card and 2 passport size photograph.
If you are unable to attend interview you can share cv on chandanid@amnealindia.com, neha.modi@amnealindia.com, kishan.soni@amnealindia.com
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