Jr. Executive - Hyderabad, India - STANEX DRUGS & CHEMICALS PVT LTD
1 week ago
Description
Roles & Responsibilities Responsible for Operation of Vial/Ampoule/PFS machine. Hands-on experience in Vial filling, washing, and sealing. Coordination with the Engineering department during preventive maintenance and machine breakdowns.Responsible for the smooth operation of the machine and giving the desired output in the scheduled timelines with defined cGMP standards.
Education Qualification- (ITI / Diploma / BSc (Chemistry, Microbiology) M.Sc(Chemistry, Analytical, Organic, Microbiology), B.Pharmacy, M.PharmacyKey Skills
- Sterile Injectable exposure in Compounding, Filling, Sealing, Washing & Line Management, QMS, Machine operator, Line Chemist, BPCR ReviewSalary
- As per Industry norms————————
Roles & Responsibilities:
- Responsible for giving the line clearance for the manufacturing/Packing. Responsible for Inprocess checks to ensure manufacturing and packing activities performed as per the instructions mentioned in the BPCR and cGMP. Responsible for a sampling of Intermediate and finished products. Responsible for online completion of BPCR.Education Qualification
- B.Sc(Chemistry, Microbiology) M.Sc(Chemistry, Analytical, Organic, Microbiology), B.Pharmacy, M.PharmacyKey Skills
- IPQA, Line Clearance, In Process, BPCR, Manufacturing & PackingSalary
- As per Industry norms————————
Roles & Responsibilities:
- Analysis of Raw materials, Finished, Stability, and packing materials using different instruments.
- Maintaining Good Documentation PracticesEducation Qualification:
- B.Sc(Chemistry) M.Sc(Chemistry, Analytical, Organic Chemistry), B Pharmacy, M.PharmacyKey Skills
- Quality control, QC, Quality AnalystSalary
- As per Industry norms————————
- Roles & Responsibilities
- Microbiology testing and monitoring
- Media dispensing for media fill trials. Maintaining related raw data and logbooks. Maintaining Good Laboratory Practices.
- BSc (Microbiology)
MSc( Microbiology, Biotechnology)Key Skills:
Microbiology Monitoring, Microbiology Testing, MLT, BET
- Roles & Responsibilities:
- Analysis of Raw materials, Finished, Stability, and packing materials using different instruments.
- Maintaining Good Laboratory practices
- Maintaining Good Documentation Practices
- Method Development
Roles & Responsibilities:
- Responsible for giving the line clearance for the manufacturing/Packing.
- Responsible for Inprocess checks to ensure manufacturing and packing activities were performed as per the instructions mentioned in the BPCR and cGMP.
- Responsible for a sampling of Intermediate and finished products.
- Responsible for online completion of BPC
Roles & Responsibilities:
- .Co-ordinate with Departments like QA, QC,Production, Ware House
.Generating POs
.Co-ordinate with Vendors, Clients
Roles & Responsibilities:
- Document Management of Issuance & control of formats, Log books, protocols, BMR, Cleaning records etc.
Inter departmental Coordination & Assist the Training Coordinator to form the training sessions for all employees.
Issue & Review of batch manufacturing records and other documents.
Issue & Retrieval of all the log books and documents.
Participate in IPQA and Dispatches activities whenever required.
Preparation of stability data.
To give the line clearance for further step of batch manufacturing.
Preparation of Annual Product Quality Review Reports (APQR).
Responsible for overall cGMP compliance at the facility.
Responsible to perform any other activity assigned by Manager-QA.
Roles & Responsibilities:
-
Literature search
Instrument (pH meter, Balance etc.,) calibration and maintenance
Lab maintenance
Pre-formulation studies
Lab note book, log books etc., up dation
Preparation of stability protocols and stability loading, with drawl submission to ARD
Development trials execution
Protocol bound trials execution (photostability, compatibility, thermal excursion and temperature excursion etc.)
Reconciliation of raw materials
Compilation of all analytical reports and interpretation
Test licence document preparation
Technology transfer documents preparation
Scaleup and submission batches execution at commercial site
Documentation support to filing & coordination of cross functional teams
Other works allotted by superior
Salary:
₹10, ₹15,000.00 per month
Benefits:
- Health insurance
- Paid sick time
- Provident Fund
Schedule:
- Day shift
Supplemental pay types:
- Overtime pay
- Yearly bonus
Ability to commute/relocate:
- Hyderabad, Telangana: Reliably commute or planning to relocate before starting work (required)
- Health insurance
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