Opening for
Quality Control – HPLC
Experience:
2-7 yrs
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
Candidates should also have sound knowledge cGMP documentation and must
be familiar with cGMP requirements.
Opening for Production
- OSD Packing
Experience:
2-5 yrs
Job Purpose:
This position provides front line leadership to direct reports in support
of packing of drug products and drives a culture of compliance, ownership and
continuous improvement with thorough working knowledge of equipment, processes
and systems.
Key Accountabilities/
Responsibilities
1. All Packing Material and Manpower Handling
- Supervise cleaning activity of blister and
strip machines.
- Provide training to technicians for machines,
equipment operation and for line clearance activities.
- Cross check the readiness of area, machine,
temperature, humidity, differential pressure and di -punch as per SOP
before going for line clearance.
2. Tablet and Capsule Process
- Supervise the process of online machine
activity of tablets and capsule with blister and strip packing.
- Ensure the tablets and capsules are packed in
appropriate strip and blister as per the SOP.
- Provide training to technicians for operating
tablets and capsule packing machines.
- Ensure pre availability/supply of tablets for
strip and blister packing machine.
3. Sample Activity
- Checks the sample tablet availability in
quarantine area.
- In BPR maintain batch registered for tablet
sample as per the unit count
4. Manpower Handling
- Supervise the packing activity of tablet and
ensure compliance to all GDP and GMP requirements.
- Support the team members in resolving problems
related to machines and packing processes.
- Distribute the responsibilities among team
members based on the planning.
5. Leak Test
- Supervise the full leak test activity and check
machine temperature, strip pressure and vacuum pressure as per BPR.
- Maintain strip and blister in process variation
and if any problem found at these stage inform to operator.
6. BPR Activities
- Perform blister cutting and coating, hologram
activities and in process of strip packing.
- Enter leak test temperature and working
condition in BPR
- Enter carton coding and line clearance activity
related to previous product stereo restoring.
- Enter data of tablet and capsule process in BMR
with date, release status, drums weight.
7. Others
- Any other responsibility assigned by management
in the favor of organization.
- Transfer the PVC/ Alum- alum scarp of tablets
and capsule to waste room.
- Enter details and perform overall process of
equipment log book.
For all the positions, candidates should also have sound knowledge cGMP
documentation and must be familiar with cGMP requirements.
Opening For
Regulatory Affairs (Europe Market)
Experience:
3-6 yrs
Key
Accountabilities/ Responsibilities
- Work on variety of Regulatory related
submissions
- Ensure timely authoring and submission of
dossiers (Module 2-5) for regulated regions such as Europe, Australia,
South Africa, New Zealand and Canada in the eCTD format including
familiarity with publishing activities.
- Preparation of quality responses to the
deficiency letters from various agencies within agreed time frame.
- Co-ordinate with various departments to obtain
essential scientific data and documents required for dossier preparation
and query responses.
- Involve in review of source documents for
in-house: product development report, specification (excipients, API and finished
product), manufacturing batch record, analytical method, validation
report, validation protocol etc.
- Actively participate in the evaluation of
regulatory compliance of document/product/ process/test methods changes.
- Identification of correct change code and
authoring of variation package to maintain product life cycle in a timely
manner.
- Provide regulatory insights and support for
contract manufacturing projects (CMO/CDMO).
- Preform gap analysis for extension of dossier
to other territories as per country specific requirements.
- Identifies and communicates risks and issues
impacting project progression.
- Assist in the development of Regulatory CMC
strategies for assigned products and projects.
- Update/Maintenance of database with regulatory
submission and approval.
- Any other regulatory activity as per the
business needs.
Desired
Candidate Profile
- Experience in regulated markets for IR and
modified solid oral dosage form (Europe, Canada, Australia).
- Work exposure: Candidate(s) having previous
exposure in EU product life cycle management/variation and Health Canada
filings are preferable.
- Core competencies: Strong technical
understanding of ICH/EU/Health Canada guidance, time management skills,
right first time approach, work with minimal supervision.
For all the positions, candidates should also have sound knowledge cGMP
documentation and must be familiar with cGMP requirements.
Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm
Location: Ahmedabad
Interested candidates may also email their resume to career@unisonpharmaceuticals.com
OUTCALL CALL GIRL
ReplyDeleteAIRHOSTESS ESCORTS