Amneal Pharmaceuticals Walk-In Interview for
Multiple Positions on 1st Dec 2019
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
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
Position: 20
Area: Technology Transfer, RM, FP, Stability, LIMS
Desired Profile:
Able to perform sampling of raw-materials and packing materials
within the specified time frame to support manufacturing activities.
Should have experience to perform analysis & documentation of
Raw-materials, In-process, Finished products, stability & validation
samples by using Caliber LIMS software
Exposure to for management of working/reference standards on
Caliber LIMS
Should have exposure to perform analytical method transfer, method
verification and method validation activities as per ICH guideline and as per
SOP’s
Exposure to prepare and standardization of volumetric
solutions/reagents
Responsible to perform all activities in laboratory in GLP
compliance manner
Caliber LIMS knowledge is preferable
INJECTABLE REQUIREMENT
Quality Assurance (IPQA) – Injectable unit /Parenteral Unit)
Designation: Officer
Qualification: B.Pharm/M.sc Microbiologist
Total Experience: 01 to 03 years
Position: 5
Responsible for preparation, review and implementation of Standard
Operating Procedures of Quality Assurance department.
Should have sound knowledge and experience in Environmental
Monitoring (Air Sampling, Settle Plate, Surface Monitoring, Personnel
Monitoring)
Responsible for the review of BMR/BPR.
Responsible for Document management like BMR’s, BPR’s, Master
SOP’s, training records etc.
Responsible for reserve sample management, annual review and
destruction as per Procedure.
Responsible for tracking of stability sample collection as per
protocol.
Responsible for stage wise line clearance activity before
commencing the operations like dispensing, manufacturing, filling,
Lyophilization, sealing, labelling and packing operations.
Supervision of sampling activity for in process and finished
samples for analysis and other samples requirement as per protocols (Process
Validation, Cleaning Validation etc.)
Responsible to provide and fulfill the documents requirement of
regulatory affairs department for filing or other requirements.
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.
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
Position: 10
Area: GLP, Calibration, QC QMS, LIMS, Stability
Testing of raw material, packing material, in-process, finished
product and stability samples (as per stability protocol).
To keep neat and cleanliness at work place and follow the Good
laboratory practices in the laboratory.
To keep update of instrument slog-books and to record the data in
LNB during testing. To attain and complete self-training record.
To initiate and review of A)Deviation B)Out of specification/Out
of trend C)Change control
To ensure in and out of stability samples from stability chambers.
Charging of stability samples as per stability protocol.
To perform water analysis as per specification, SOP and GTP.
To co-ordinate QA for documentation for issuance and retrievals.
Review and monitoring of USP, EP, BP and other pharmacopeia
monographs for changes/ revision.
To prepare COA of various product/material as per requirement
whenever required.
LIMS master preparation for various product / material/
instruments/ Volumetric solutions etc.
Registration of reference standard, working standard, column,
instrument etc. in LIMS
Preparation/updating of calibration schedule in LIMS
Updating of LIMS master as and when required
Preparation of configured Test plan.
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:
To handle miscellaneous material and tertiary packaging material’s
vendor qualification as per procedure.
To prepare and update vendor list as per procedure and maintain
vendor qualification documents.
Review and implementation of vendor notification/declaration
provided by SSSM from respective vendor at site.
To review commercial artwork component and hand over to QA doc
cell for distribution.
To handle the contract agreement as per procedure
To review test results comparison report of API/ Excipients against
manufacturer’s certificate of analysis and Amneal’s certificate of analysis for
vendor qualification.
To maintain regulatory commitment log.
To prepare and review standard operating procedures of Quality
Assurance Department.
Responsible for document handling, issuance, distribution and
retrieval of documents
Activities other than that defined in the job description are to
be done, as per the requirements instruction / guidance of HOD.
To log the change controls received from various departments.
To handle the changes carried out in the location by assessing the
risks associated with it as per the change control procedure.
To prepare standard operating procedures of Quality Assurance
Department and review the SOPs of cross functional departments.
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.
To conduct or be a part of team conducting risk assessment of
various activities, equipment, systems, etc. in the location.
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.
Follow up with various departments for completion of activities
assigned in the change control.
To review updated guidelines and inform gaps in the current
practices to respective department heads and quality assurance head for its
compliance.
Collection of data required for preparation of management review
report.
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.
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:
To maintain master documents like Site Master File, Validation
master plan, Quality Manual, SOP, Batch records, protocols, specifications, drawings,
etc.
Responsible for preparation, revision and review of standard
operating procedure of QA department and review the SOPs of cross functional
departments.
To prepare and maintain the Site master file and Quality manual.
Issuance of approved Standard Formats and Log books to User
Departments. To ensure that only authorized formats are issued.
To receive the product development documents like Master Formula
Records, Master Packaging records, protocols (sampling, study and stability
protocols).
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.
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.
Responsible for issuance archival and retrieval of documents like
SOPs Validation / qualification protocols / reports Batch records
Specifications Drawings Artworks Approved Vendor List Planner etc
Responsible for verification of documents like Batch Manufacturing
records Batch Packaging Records Protocols SOPs Specifications etc.
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
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