Amneal | Walk-in at Ahmedabad for Multiple Positions on 1 Dec 2019 | Pharma Jobs in Ahmedabad

We are looking for competent, dynamic and motivated candidates for suitable positions for Injectable & OSD (oral solid dosage) unit for our Ahmedabad SEZ Matoda Plant.

Date: 1st December,2019 (Sunday)
Timing: 9:00 AM to 12:00 PM

Venue:
Amneal Pharmaceuticals Pvt. Ltd.
Plot No 15,16,17 Pharmez
Village: Matoda
Sarkhej Bavla Road, Abad

Please find the Job details below :

OSD REQUIREMENT

1. Quality Control (QC - OSD)
Designation: Officer/ Sr. Officer/ Executive
Qualification: B.sc/ M.sc /B.pharm /M.pharm
Total experience: 02 to 07 years

Position: 20
Area : Technology Transfer, RM, FP, Stability, LIMS

Desired Profile :

1. Able to perform sampling of raw-materials and packing materials within the specified time frame to support manufacturing activities.

2. Should have experience to perform analysis & documentation of Raw-materials, In-process, Finished products, stability & validation samples by using Caliber LIMS software

3. Exposure to for management of working/reference standards on Caliber LIMS

4. Should have exposure to perform analytical method transfer, method verification and method validation activities as per ICH guideline and as per SOP's

5. Exposure to prepare and standardization of volumetric solutions/reagents

6. Responsible to perform all activities in laboratory in GLP compliance manner

7. Caliber LIMS knowledge is preferable

INJECTABLE REQUIREMENT

1. Quality Assurance (IPQA) - Injectable unit /Parenteral Unit)

Designation: Officer
Qualification: B.Pharm/M.sc Microbiologist
Total Experience: 01 to 03 years

Position: 5

1. Responsible for preparation, review and implementation of Standard Operating Procedures of Quality Assurance department.
2. Should have sound knowledge and experience in Environmental Monitoring (Air Sampling, Settle Plate, Surface Monitoring, Personnel Monitoring)
3. Responsible for the review of BMR/BPR.
4. Responsible for Document management like BMR's, BPR's, Master SOP's, training records etc.
5. Responsible for reserve sample management, annual review and destruction as per Procedure.
6. Responsible for tracking of stability sample collection as per protocol.
7. Responsible for stage wise line clearance activity before commencing the operations like dispensing, manufacturing, filling, Lyophilization, sealing, labelling and packing operations.
8. Supervision of sampling activity for in process and finished samples for analysis and other samples requirement as per protocols (Process Validation, Cleaning Validation etc.)
9. Responsible to provide and fulfill the documents requirement of regulatory affairs department for filing or other requirements.
10. Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD's instruction and guidance.

2. Quality Control - (Injectable unit /Parenteral Unit)

Designation: Officer/Sr. Officer/Executive
Qualification: B.sc/ M.sc/ B.pharm/ M.pharm
Total experience: 02 to 07 years

Position: 10

Area: GLP, Calibration, QC QMS, LIMS, Stability

1. Testing of raw material, packing material,in-process,finished product and stability samples (as per stability protocol).
2. To keep neat and cleanliness at work place and follow the Good laboratory practices in the laboratory.
3. To keep update of instrument slog-books and to record the data in LNB during testing. To attain and complete self-training record.
4. To initiate and review of A)Deviation B)Out of specification/Out of trend C)Change control
5. To ensure in and out of stability samples from stability chambers.
6. Charging of stability samples as per stability protocol.
7. To perform water analysis as per specification, SOP and GTP.
8. To co-ordinate QA for documentation for issuance and retrievals.
9. Review and monitoring of USP, EP, BP and other pharmacopeia monographs for changes/ revision.
10. To prepare COA of various product/material as per requirement whenever required.
11. LIMS master preparation for various product / material/ instruments/ Volumetric solutions etc.
12. Registration of reference standard, working standard, column, instrument etc. in LIMS
13. Preparation/updating of calibration schedule in LIMS
14. Updating of LIMS master as and when required
15. Preparation of configured Test plan.
16. Trouble shooting in LIMS, Involve in Qualification of LIMS  module/ Instrument, Preparation of LIMS related protocol study and execution.

Department: QMS

Area: QMS - Deviation, Vendor Qualification

Position: 2

Qualification: M. Pharm

Experience:3 to 6 Years

JD:

1. To handle miscellaneous material and tertiary packaging material's vendor qualification as per procedure.

2. To prepare and update vendor list as per procedure and maintain vendor qualification documents.

3. Review and implementation of vendor notification/declaration provided by SSSM from respective vendor at site.

4. To review commercial artwork component and hand over to QA doc cell for distribution.

5. To handle the contract agreement as per procedure

6. To review test results comparison report of API/ Excipients against manufacturer's certificate of analysis and Amneal's certificate of analysis for vendor qualification.

7. To maintain regulatory commitment log.

8. To prepare and review standard operating procedures of Quality Assurance Department.

9. Responsible for document handling, issuance, distribution and retrieval of documents

10. Activities other than that defined in the job description are to be done, as per the requirements instruction / guidance of HOD.

11. To log the change controls received from various departments.

12. To handle the changes carried out in the location by assessing the risks associated with it as per the change control procedure.

13. To prepare standard operating procedures of Quality Assurance Department and review the SOPs of cross functional departments.

14. To carry out investigations to the deviations, market complaints, OOS, OOTs, etc. by using appropriate root cause analysis tools, assessing the risk associated with them and ensuring compliance of the non- conformance as per the cGMP by documenting it through the CAPA system.

15. To conduct or be a part of team conducting risk assessment of various activities, equipment, systems, etc. in the location.

16. To analyse and trend the deviations, market complaints and other non-conformance served in the location to identify any repetitive observations for its further investigation, risk assessment and CAPA.

17. Follow up with various departments for completion of activities assigned in the change control.

18. To review updated guidelines and inform gaps in the current practices to respective department heads and quality assurance head for its compliance.

19. Collection of data required for preparation of management review report.

20. To co-ordinate regulatory / customer audits conducted at the location, recording the day to day activities, informing the same to the management, coordinate with respective department for online compliance (if required) and provide the compliance to the audit observations by coordinating with respective departments and guidance of the HOD within the stipulated timeline.

21. Activities other than that defined in the job responsibility are to be done as per the requirements / instruction / guidance of HOD

Department: QA Document Cell

Position: 1

Experience: 2 to 6 Years

Qualification: B. Pharm/ M. Pharm

JD:

1. To maintain master documents like Site Master File, Validation master plan, Quality Manual, SOP, Batch records, protocols, specifications, drawings, etc.

2. Responsible for preparation, revision and review of standard operating procedure of QA department and review the SOPs of cross functional departments.

3. To prepare and maintain the Site master file and Quality manual.

4. Issuance of approved Standard Formats and Log books to User Departments. To ensure that only authorized formats are issued.

5. To receive the product development documents like Master Formula Records, Master Packaging records, protocols (sampling, study and stability protocols).

6. To co-ordinate regulatory / customer audits conducted at the location, recording the day to day activities informing the same to the management, coordinate with respective department for online compliance (if required) and provide the compliance to the audit observations by coordinating with respective departments and guidance of the HOD within the stipulated timeline.

7. Activities other than defined in the Job responsibility are to be done as per the requirement of HOD by following HOD's instruction and guidance.

8. Responsible for issuance archival and retrieval of documents like SOPs Validation / qualification protocols / reports Batch records Specifications Drawings Artworks Approved Vendor List Planner etc

9. Responsible for verification of documents like Batch Manufacturing records Batch Packaging Records Protocols SOPs Specifications etc.

10. To provide requisite documents to regulatory affairs department for regulatory submission whenever required.

The candidate with good communication and inter personal skills computer knowledge and exposure to cGMP/ GLP Knowledge and understanding of regulatory requirement is essential.

Note : Candidate should have 02 to 07 years of relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliance) organisation. You may walk in for 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.

If you are unable to attend interview you can share cv on chandanid@amnealindia.com neha.modi@amnealindia.com 
kishan.soni@amnealindia.com   

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