Amneal Pharmaceuticals Recruitment 2021 B.Sc/ Diploma / ITI/B.Pharm/M. Pharm/ M.sc Microbiologist Freshers & Expereince for Operator/Officer/Sr. Officer/ Executive At Ahmedabad.Amneal Pharmaceuticals Notification full detailes below.Interested and eligible candidates can Send Your resume.
- Vacancy details:
- Department:Sterile Manufacturing (Injectable/Parenteral Unit)/Quality Assurance (IPQA/EM/Validation) – Injectable unit /Parenteral Unit)/Quality Control – (Injectable unit /Parenteral Unit)/Engineering (Injectable unit /Parenteral Unit)
- Post Name: Operator/Officer/Sr. Officer/ Executive
- Qualification: B.Sc/ Diploma / ITI/B.Pharm/M. Pharm/ M.sc Microbiologist
- Experience:02 to 7 yrs
Job Description: Amneal Pharmaceuticals Hiring For Operator/Officer/Sr. Officer/ Executive !
Important Details :
- Post of date: 22/10/2021
- Note:interested candidates can share CV on firstname.lastname@example.org & email@example.com
- Contact:Mayuri Muneshwar
- Selection Process: The selection will be on the basis of Interview.
Job Description :
1. Sterile Manufacturing (Injectable/Parenteral Unit)
Qualification: B.Sc/ Diploma / ITI
Total Experience: 02 to 8 years
Area: Aseptic & Controlled area operation (Filling, Sealing, filtration, intervention, Production QMS, Autoclave, Batch Manufacturing, terminal sterilization etc.) and Packing
Line: Ophthalmic, Packing, PFS and Vial Line
Machine Exposure: Groninger & Fedegari
- To observe & follow all rules and regulations of the production department.
- Must be from Parenteral background & exposure to filling process is desirable.
- To be aware and responsible for achieving quality objective and fulfilling the requirements of applicable quality procedures.
- Sound technical knowledge of Aseptic area & Controlled area related activities.
- Technical exposure and expertise on filling & Autoclave machine.
- Knowledge of Regulatory guidelines and exposure of USFDA audits.
- Knowledge of Quality Management System (QMS) i.e. change control, Deviation, CAPA, and documentation in manufacturing area of injectable.
- Expertise in batch manufacturing and preparation related activities.
- Knowledge of equipment validation and qualifications in injectable.
- Preparation & review of BMR-BPR
- Preferred Exposure for Ophthalmic line: Three piece sterile eye drop filling machine operation (groninger), Nanomill Operation, autoclave (Fedegari) Manufacturing and Filtration vessel operation, CIP and SIP processing
2. Quality Assurance (IPQA/EM/Validation) – Injectable unit /Parenteral Unit)
Designation: Officer/Sr. Officer/ Executive
Qualification: B.Pharm/M. Pharm/ M.sc Microbiologist
Total Experience: 02 to 06 years
JD: IPQA, Line Clearance, Environment monitoring, Process validation, calibration, qualification, etc.
- Responsible for preparation, review and implementation of Standard Operating Procedures of Quality Assurance department.
- Should have sound knowledge and experience in Environmental Monitoring (Air Sampling, Settle Plate, Surface Monitoring, Personnel Monitoring)
- Responsible for stage wise line clearance activity before commencing the operations like dispensing, manufacturing, filling, Lyophilization, sealing, labelling and packing operations.
- To review test results comparison report of API/ Excipients against manufacturer’s certificate of analysis and Amneal’s certificate of analysis for vendor qualification.
- Review and implementation of vendor notification/declaration provided by SSSM from respective vendor at site.
- To prepare standard operating procedures of Quality Assurance Department and review the SOPs of cross functional departments.
- To handle the changes carried out in the location by assessing the risks associated with it as per the change control procedure.
- exposure of process validation, calibration, equipment qualification, protocol preparation
3. Quality Control – (Injectable unit /Parenteral Unit)
Qualification: M.sc/ B.pharm/ M.pharm
Total experience: 02 to 04 years
Area: GLP, Calibration, HPLC, QC-QMS, LIMS, Stability, RM, PM, FP, IP, Stability, Analysis, Testing, reviewer etc.
- Testing of raw material, packing material, in-process, finished product and stability samples (as per stability protocol).
- To keep neat and cleanliness at work place and follow the Good laboratory practices in the laboratory.
- To keep update of instrument slog-books and to record the data in LNB during testing. To attain and complete self-training record.
- To initiate and review of A)Deviation B)Out of specification/Out of trend C)Change control
- To ensure in and out of stability samples from stability chambers.
- Charging of stability samples as per stability protocol.
- To perform water analysis as per specification, SOP and GTP.
- To co-ordinate QA for documentation for issuance and retrievals.
- Review and monitoring of USP, EP, BP and other pharmacopeia monographs for changes/ revision.
- To prepare COA of various product/material as per requirement whenever required.
- LIMS master preparation for various product / material/ instruments/ Volumetric solutions etc.
- Registration of reference standard, working standard, column, instrument etc. in LIMS
- Preparation/updating of calibration schedule in LIMS
- Updating of LIMS master as and when required
- Preparation of configured Test plan.
- Trouble shooting in LIMS, Involve in Qualification of LIMS module/ Instrument, Preparation of LIMS related protocol study and execution.
Engineering (Injectable unit /Parenteral Unit)
Qualification: Diploma Engineering/ ITI (Electrician only)
Total Experience: 02 to 07 years
Area: Plant Maintenance, Electrician, instrumentation
Line: Vial, PFS and Ophthalmic
Positions: Operator: 3
- Carryout the preventive maintenance of all above mention systems as per procedure.
- Attend the breakdown on immediate basis in all above mention systems as per breakdown maintenance procedure.
- Responsible to handle the routine breakdown & maintenance activity of plant machinery.
- Responsible to perform the preventive maintenance activity of plant machinery as per PM schedule and as per respective SOP.
- Responsible to assist engineer in installation & commissioning of plant machinery.
- Responsible to generate tools and parts requirement for daily breakdown and preventive maintenance
- Responsible to intimate the shift engineer immediately for critical breakdown.
- Responsible to report the shift engineer for daily breakdown and its corrective action.
- Responsible to carry out all work as per cGMP and GEP
- Responsible to carry out preventive maintenance as per PM checklist and SOP
- Responsible to maintain all necessary documentation as per regulatory/saturatory requirements.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our team is working to build one of the most dynamic pharmaceutical companies in our rapidly changing industry.