NEXTUS SOLUTIONS is a professionally managed organization engaged in offering highly acclaimed consulting, Training and Placement. With our in- depth expertise and rich experience in the field of domestic as well as international level, we have been serving aspiring candidatesand organizations in the most professional way. We have excellent support of varied resources for meeting the needs of the clients and candidates as per their exact requirements.
POSTS:
- Deputy General Manager / Assistant Manager - Production {Below}
Post: Deputy General Manager / Assistant Manager - Production
Job Description:
1 Manufacturing of Sustained & modified release, Pellets, DC granules, Taste mask Granules, Tablets & Capsules.
2 Preparation of Monthly, Weekly Production schedule.
3 Independent Handling of various equipments and instrumentals viz Fluidized Bed Equipment 250 Combo, Spheroniser, Octagonal Blender, Planetary Mixer, Vibratory Sifter.
4 Documents filling like Batch Manufacturing Record, Test Request Form, Product Release Form, Daily log book maintenance.
5 Trouble shooting of problems arising in routine activities
6 Bulk packing of pellets for export oriented unit as well as for local market.
7 Standard operating proceduere (SOP) preparation and maintenance.
8 Good command on preparatory work for Audits (MHRA, USFDA, FDA).
9 Training to workman and Junior staffs.
10 Planning & execution of Scale-up, Exhibit & Process validation batches for New products & Execute Production plan within set deadlines.
11 Timely preparation of production documents for regulatory approval.
12 Co-ordination with other departments within the plant as well as with other locations.
13 Conducting periodic self-audits.
14 Maintaining positive & healthy work atmosphere.
15 Providing a scope for self-development for the team members.
Additional Information:
Experience: 7 Years & above
Location: Mahad - Raigad
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Production
End Date: 20th July, 2012
Forward your resume at, pharma.nextus@yahoo.com
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Post: Deputy General Manager / Assistant Manager - QA
Job Description:
1 Manufacturing of Sustained & modified release, Pellets, DC granules, Taste mask Granules, Tablets & Capsules.
2 Should have faced and cleared MHRA, USFDA, FDA).
3 Review of Technical reports for process evaluation batches (optinization) & planning of feasibility, scale-up & exhibit batches.
4 To provide inputs in the product development briefs on the technical feasibility.
5 To perform DQ, IQ, OQ, & PQ of equipments & to performing process validations & cleaning validations.
6 To ensure vendor qualification on time & also responsible for compalicance of various cGMP monitoring tools like internal quality audits, in process testing, line clearance etc.
7 To responsible for reviews & timely submission of various documents (MFR, BMR, BPR, validation reports ) & prepration & approval of Annual product reviews.
8 To ensure compliance of in process checks, sampling & daliy monitoring records.
9 To prepare & maintain SOP, Process validation equipments/Instrument qualification, protocl data compilation, monitor routine, calibration checkks & qualification reports.
10 Options of manifacturing sites, available technologies, PTS, opportunities relevent for the introduction of new products/Packing introduction.
11 Training to workman and Junior staffs.
Additional Information:
Experience: 7 Years & above
Location: Mahad - Raigad
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 20th July, 2012
Forward your resume at, pharma.nextus@yahoo.com
Get More Jobs on NEXT PAGE...
Subscribe to Pharmatutor Job Alerts by Email
Post: Deputy General Manager / Assistant Manager - QA
Job Description:
1 Manufacturing of Sustained & modified release, Pellets, DC granules, Taste mask Granules, Tablets & Capsules.
2 Should have faced and cleared MHRA, USFDA, FDA).
3 Day to day activites like preparation of specifications and analysis of samples as per customer requirement.
4 Product development and document support with various customers for ANDA filing.
5 Review of retention sample data of all the products batches to ensure storage condition and simulation packing.
6 Calibration of instruments as per schedule and maintenance as per Annual Maintenance Schedule.
7 Experience with operation of HPLC, GC, IR activites.
8 Training to workman and Junior staffs.
9 Analytical method transfer for ANDA & Review of Methode Transfer.
10 Should have strong Analytical Skills; Knowledge of QA, QC analysis and interpretation of results, cGMP and GLP Analysis and Trouble shooting in analysis.
11 Stability study, inprocess study & Holding Time study.
12 Techonology Transfer of analytical method For different test e.g. Assay Dissolution and Related substancesby using HPLC , UV etc .
13 Preparation and review of Complete analytical data for Method validation, Method transfer.
14 Calibration of Dissolution Tester & Balance used in Q. C. Lab & Maintaining the records.
15 Maintenance of various documents like Logbooks & other daily, weekly & monthly records.
Additional Information:
Experience: 7 Years & above
Location: Mahad - Raigad
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QC
End Date: 20th July, 2012
Forward your resume at, pharma.nextus@yahoo.com
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