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0.0 years
0 Lacs
hyderabad, telangana, india
On-site
Job Description Responsible for routine monitoring of Manufacturing Areas. Responsible for the routine GMP Inspection & review of Quality Records of other departments. To monitor and ensure compliance level of organization is as per current GMP requirement Good Documentation recording and updation. Responsible for review of URS, DQ and vendor / suppliers documents related to qualification. Responsible for preparation of Validation / Qualification protocol and report. Responsible for execution and review of qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant Utilities. Responsible for adequacy of execution of validations being carried out at pre...
Posted 3 weeks ago
0.0 years
0 Lacs
hyderabad, telangana, india
On-site
Job Description Responsible for routine monitoring of Manufacturing Areas. Responsible for the routine GMP Inspection & review of Quality Records of other departments. To monitor and ensure compliance level of organization is as per current GMP requirement Good Documentation recording and updation. Responsible for review of URS, DQ and vendor / suppliers documents related to qualification. Responsible for preparation of Validation / Qualification protocol and report. Responsible for execution and review of qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant Utilities. Responsible for adequacy of execution of validations being carried out at pre...
Posted 3 weeks ago
10.0 - 12.0 years
0 Lacs
itanagar, arunachal pradesh, india
Remote
Job Type : Long-Term Contract About The Role We are looking for an experienced CSV Lead with deep expertise in Computer System Validation, SAP S/4HANA upgrades, and strong Japanese language proficiency (JLTP N1). This is a remote, long-term contractual role ideal for a proactive professional who can manage validation activities and compliance processes independently while collaborating in a global, cross-functional environment. Key Responsibilities Lead and manage CSV (Computer System Validation) activities across the project lifecycle, including concept, implementation, operations, and retirement phases. Work closely with teams involved in SAP S/4HANA upgrade initiatives. Review and approve...
Posted 1 month ago
10.0 - 15.0 years
0 Lacs
mumbai, maharashtra, india
On-site
Company Description AMN Life is a leading manufacturer and exporter of a wide range of formulations in various therapeutic segments including antibiotics, gastro, anti-inflammatories, cardiology, nephrology, CNS, and oncology. With facilities approved by EU, Health Canada, Brazil - Anvisa, and Philippines situated in Bhilad (Gujarat) and Kala Amb (Himachal Pradesh), AMN Life is equipped to handle large scale production and tech transfer projects. Headquartered in Bandra Kurla Complex, Mumbai, with offices in Singapore, UK, Australia, and Philippines, AMN Life excels in providing quality medicines at affordable prices globally. We are recognized for our strong global presence, innovative R&D,...
Posted 1 month ago
0.0 years
0 Lacs
Mumbai, Maharashtra, India
On-site
Major Accountabilities Process / Send technical complaints to CMO / Supplier for investigation. Co-ordinate for complaint sample availability, additional information from Country Organization (CO) to CMO (Contract Manufacturing Organization) and vice versa as and when required. Periodic follow of complaints with supplier for timely investigation. Perform queries in QMS tools like GxQEM as per the procedures. Reviewing of supplier investigations and completing it in QMS tool for complaints delegated to GQSI. Perform the role of QA approver for complaints delegated to GQSI. Tracking and extension of complaint / actions as per the requirements. Complete the assigned tasks as per business need. ...
Posted 3 months ago
10.0 - 12.0 years
11 - 12 Lacs
Tumkur, Bengaluru
Work from Office
Job Description Triveni Hi- Tech Private Limited is looking for an experienced QMS Manager / Management Representative (MR) to lead and manage our Quality Management System (QMS) as per AS9100 standards. The ideal candidate will ensure compliance, continuous improvement, and maintain high-quality standards as per Aerospace Industry requirements. Responsibilities: Oversee and uphold the Quality Management System (QMS) in accordance with AS9100 and customer specifications. Serve as the Management Representative (MR) during customer, third-party, and certification audits. Perform internal audits, detect non-conformities, and facilitate corrective and preventive actions (CAPA). Document the minu...
Posted 4 months ago
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