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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