Walk-in-interview on 25th Oct for Multiple Positions in Sterile Production/Quality/Microbiology at Matoda, Ahmedabad
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.
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Our leadership and global colleagues are deeply experienced and forward-thinking. We have the capabilities, scale, and resources for growth and success. We are nimble and determined. We are Amneal and We make healthy possible.
We’re looking for entrepreneurial-minded team players who want to join hearts and minds in our quest to make healthy possible.
We’re looking for individuals who bring innovative ideas, a willingness to challenge the status quo, and a focus on delivering value and results. We also look for people who enjoy their work, want to grow with us, engage in our Responsibility commitments, and make a difference for our company, our patients, and our shareholders.
We are looking for competent, dynamic, and motivated candidates for suitable positions for the Injectable unit for our Ahmedabad SEZ Matoda & Sachana Plant.
Position: Executive/Sr. Officer/Officer/Operators
Department: Sterile Manufacturing ( Injectable unit /Parenteral Unit)
Location: Matoda, Ahmedabad, Gujarat, India
Sterile Manufacturing ( Injectable unit /Parenteral Unit)
JOB location: SEZ Matoda
Designation: Sr. Officer/ Officer/ Operators
Qualification: B.Pharm/ Diploma Engineering/ D. Pharm/ B.Sc/ ITI
Total Experience: 02 to 07 years
Area: Aseptic and Control area (Filling, Documentation, CIP, SIP, autoclave, Batch Manufacturing)
Positions: Officer-13 & Operator-30
- To observe & follow all rules and regulations of the production department.
- Must be from Parenteral background
- To be aware and responsible for achieving the quality objectives and fulfilling the requirements of the quality of the company’s service by means of applicable quality procedures.
- Sound technical knowledge of the Aseptic area and controlled are related activities.
- Technical exposure and expertise in filling & Autoclave machine.
- Knowledge of Regulatory guidelines and exposure of USFDA audits.
- Knowledge of Eye drop filling machine and related batch mfg. process.
- Knowledge of Quality Management System (QMS) i.e. change control, Deviation, CAPA, and documentation in the manufacturing area of injectable.
- Expertise in batch manufacturing and preparation related activities.
- Knowledge of equipment validation and qualifications in injectable.
- 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
Quality (Injectable unit /Parenteral Unit)
JOB location: Palli (Sachana-Kadi)
Designation: Sr. Executive/Executive/Sr. Officer/ Officer
Qualification: M. Pharm/ B.Pharm/ M.Sc
Total Experience: 02 to 07 years
Area: Quality Control, Quality Control Microbiology, and Quality Assurance
Line: Bag Line
Quality Control (Bag Line)
- GLP Activities, Calibration, LIMS
- Various Analysis (Raw Material Analysis, Finished Product Analysis, In process Sample Analysis, Cleaning Validation Sample Analysis, Water Sample Analysis, Stability Sample Analysis, In-Use study Analysis
- Freeze through Study & Thermal Cycle Study
- Data Reviewer, QMS (OOS, OOT, CAPA, Change control Etc,.
- Stability Chamber and Sample management
- Reagent Management
Quality Assurance (Bag Line)
- IPQA (Line clearance, BMR-BPR review, Sample collection, In-process check, Dispensing, Etc)
- Validation Activities (SOP preparations, Initial & periodically Validation, qualification of utilities and Equipment, Cleaning Validation, Process Validation, Validation Master plan, etc.,)
- QMS Activities (Handling of Deviation, CAPA, Incident, etc)
- Doc cell Activities (Manual Issuance, Retrieval, SOP preparation, review, etc)
Quality Control Microbiology (Bag Line)
- Microbiological testing Activities ( Media Preparation & discard, Growth Promotion test, Autoclave operation, Culture handling, Equipment calibration & qualification, , Micro Lab routing documentation, Disinfection Study, etc)
- GLP, Media & Review: Activities (Sterility Testing, BET testing, Bioburden Analysis, Water sampling & analysis, Method validation / Qualification, Personal Monitoring, etc)
- Documentations (SOP Preparation, Study Protocols Preparation, Study Report Preparation, Method Validation Protocol and reports, etc)
- Environmental Monitoring (Settle plate exposure, Microbial air sampling, Surface sampling, Particle count (NVPC), Media plate observation)
For Injectable, if you are unable to attend the interview you can share cv on firstname.lastname@example.org
We are also having requirements for Manufacturing(OSD), ARD(OSD), and F&D(OSD). Interested candidates may either submit a hardcopy of their CV at the venue, or mail CV on email@example.com & firstname.lastname@example.org Candidates with a suitable profile will be scheduled for interview separately.
Required Candidate profile
- The candidate with good communication and interpersonal skills, computer knowledge, and exposure to cGMP/ GLP Knowledge and understanding of regulatory requirements is essential.
- Candidate should have 02 to 07 years of relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliance) organization.
- You may walk-in for an interview with current CV along with CTC proof Appointment letter, Increment letter & last 3 months salary slip & Bank statement, Aadhar & PAN card, and 2 passport size photograph.
- Those who have already attended interview in the last 6 month need not appear again for an interview