Openings @ Unison Pharmaceuticals Pvt. Ltd
Location: Ahmedabad
Opening for
Quality Control – GLP
Experience: 2-6 yrs
Roles and
Responsibility
- Responsible
for handling of instruments like HPLC, Dissolution Test Apparatus, UV
Spectro Photometer, Disintegration Apparatus and Other Physico Chemical
instruments.
- Responsible
for perform the Calibration of all Analytical Instruments/Equipment lying
at Quality control laboratory.
- Responsible
to perform Equipment/ Instruments Calibration/ Verification. In-case of
OOC results inform to superior immediately and follow respective SOP.
- Responsible
for maintain the Inventory, log record of HPLC columns as per respective
Column management SOP.
- Execution
of Calibration and Preventive Maintenance of QC instruments as per
predefined schedule.
- Working
Standard, Reference Standard and Chemical/Reagent management.
- When
require give the support in Analytical document preparation like SOPs ,
Specification, Method of Analysis , Worksheet , Analytical Method Transfer
Protocol and Report.
- To
follow Good Laboratory Practices (GLP), Good Documentation Practices (GDP)
and Safety precautions during routine analytical activities.
- Daily/
weekly monitoring of Temperature/ Humidity of QC laboratory.
- To
ensure availability of current version SOPs, Specifications, MOAs, STPs.
- To
prepare SOPs, Specifications, MOAs, STPs and other documents.
- Responsible
for preparation of Analytical documents like Specification, Method of
Analysis and Worksheet for Active Raw Material, Inactive Raw Material,
Finished Product, Finished Product Strip/blister, Semi Finished Product,
Granules, and Packing Material and for working standard qualification.
- Preparation
and maintenance of Miscellaneous documentation.
- Archival
and Retrieval of Quality documents.
For all the positions, candidates should also have sound knowledge cGMP
documentation and must be familiar with cGMP requirements
Opening for
Quality Control – HPLC
Experience: 2-7 yrs
Job Purpose:
The QC analyst performs various scientific analyses to evaluate the
quality of raw materials, in-process materials, and finished goods and ensure
compliance with established standards. He / She conducts and validates various
biological and chemical quality control Assay, RS, Dissolution, CU, BU, Swab
etc. He / She compiles, interprets, and documents statistical data from testing
processes to either confirm compliance with established quality standards or
identify deviations. He / She is also responsible for establishing
specifications for conducting various analyses.
Key
Accountabilities/ Responsibilities
1. HPLC Operation (Analyst)- Assay
- Collect
worksheet and sample for analysis as per plan
- Check
the instrument calibration details
- Purging
the interior part of the instrument
- Take
the columns as per worksheet and put in instrument
- Initiate
solution preparation for analysis as per worksheet which majorly includes;
Mobile Phase, Standard and sample
- Prepare
HPLC sequence for analysis and get it review by reviewer
- As
per the sequence initiate the analysis and online verify SSC criteria as
per worksheet
- Post
completion of the analysis perform documentation and send to reviewer
- Calculate
final analysis result as per the standard formula mentioned in worksheet
and match the result with worksheet range
2. HPLC Operation (Analyst)- Dissolution
- Collect
worksheet and sample for analysis as per plan
- Check
the instrument calibration details
- Purging
the interior part of the instrument
- Take
the columns as per worksheet and put in instrument
- Initiate
dissolution solution preparation for analysis as per worksheet and also
prepare dissolution medium
- Perform
dissolution analysis as per the criteria mentioned in worksheet
- Post
completion of the analysis perform documentation and send to reviewer
- Calculate
final analysis result as per the standard formula mentioned in worksheet
and match the result with worksheet range
3. HPLC Operation (Analyst)- Others
- RM-
Assay, RS, IR
- In
process- Assay by UV and HPLC
- PV
Sample- Assay by UV and HPLC, Dissolution
- FP-
Assay, Dissolution, RS, DT, Average weight, hardness, Friability, IR
- Cleaning
validation
Opening for
Production - Documentation (QMS)
Experience: 3-6 yrs
Job Purpose:
The incumbent plays major role in completing all QMS related activities
from production team. The person is responsible for coordinating and
implementation of all QMS activities for production.
Key Accountabilities/
Responsibilities
1. Quality and compliance
- Change
control- Initiation, follow-up, action plan and closing
- Deviation-
Initiation, investigation, CAPA and action plan
- Market
complain- Performing investigation related to production, root cause
identification, analysis and report preparation
- OOS
/ OOT- Investigation, root cause identification, documentation, CAPA and
action plan
- SOP-
SOP preparation, change / revision, format issuance and control
- BMR-
Master BMR and executed BMR preparation and review, correction if needed
and submission to QA
- Process
validation - Protocol review and final report review, audit trail review
(SCADA) and compliance justification
- Preparation
and submission of self-inspection compliance report
2. Others deliverables
- Job
description preparation for new employees joining in production team
- Updating
SOP master list in a frequency of 3 month or whenever needed
- Performing
batch entry process tracking and batch transfer in Pharma Cloud
- Weekly
review formats and log books for various activities like; sieve inspection
record, sieve issuance record and FBD bag issuance record
Opening for
Production – Compression
Experience: 2-6 yrs
Job Purpose
This position provides front line leadership to direct reports in support
of manufacturing of drug products and drives a culture of compliance, ownership
and continuous improvement by blending an understanding of lean concepts with a
working knowledge of equipment, processes and systems.
Key
Accountabilities/ Responsibilities
1. Production and Documentation:
- Initiate
process for taking manufacturing batch as per the schedule shared by
Production head
- Environment
monitoring of the area and filling log book for Temperature RH and
Differential pressure. Inform engineering team and get corrected, if found
any discrepancy. Verify rectifications related to discrepancy.
- Verify
weighing balance
- Checking
calibration of weighing balance and validity of preventive maintenance
- Prepare
issuance request for IPA (Iso propyl Alcohol)
- Receive
material from quarantine area for compression
- In
process check of tablets as per BMR
- Perform
metal detector challenge test
- Perform
IPQC as per frequency in BMR: Uniformity of weight, thickness, hardness,
disintegration time and friability
- Batch
reconciliation and yield calculation
- Ensure
return riser filter cleaning and area cleaning
- Sending
compressed tablets in quarantine area and making entry
- Ensure
changeover activities as per SOP
- Give
intimation to QA for IPQC sample and Line clearance after changeover
completion
2. Quality Excellence
- Ensure
adherence to SOP, GMP guidelines, BMR during the compression process
- Perform
all document related activities; BMR filling, Log books, Die punch
issuance and uses records etc. as per GDP.
- BMR
and log book entry in Pharma Cloud
- Preparing
QC sampling request for QC analysis in Pharma Cloud
- Facilitate
all applicable SOP trainings to new technicians and helper joining in the
area
3. Production Hygiene and Cleanliness
- Responsible
for maintaining cleanliness and hygiene in the compression area as per the
regulatory requirement
4. Machine Operation and Troubleshooting
- Responsible
for appropriate and efficient use of machine and equipment in the area
- Coordinate
with engineering team for any machine related troubleshooting and ensure
quick resolution to the problem
- Ensure
area readiness by checking machine calibration, preventive maintenance
status and cleanliness
- Issue
die-punch as per BMR specification and SOP and ensure inspection of
die-punches before initiating the compression activity
- Ensure
calibration validation of Inspection kit and verify food grade oil
certificate
5. New machine installation
- During
new machine installation, support Engineering, QA and Vendor team for
Installation Qualification (IQ) and Operation Qualification (OQ)
- Perform
Performance Qualification (PQ) at the time of new machine installation under
the guidance of production head
- Taking
validation batches as per the guidance of production head
6. Additional responsibilities
- Any
other responsibility assigned by management
For all the positions, candidates should also have sound knowledge cGMP
documentation and must be familiar with cGMP requirements.
Qualification: B.Sc / B.Pharm / M.Sc / M.Pharm
Interested candidates may also email their resume to career@unisonpharmaceuticals.com
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