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3.0 - 8.0 years
4 - 9 Lacs
bengaluru
Work from Office
MSc/ Mpharm with 2- 8 years of relevant experience. 1.Responsible for developing, establishing and maintaining QA procedures related to clinical trials to ensure compliance to applicable regulatory guidelines. 2. Review of Clinical Trial related documents like Investigators Brochure, Clinical Trial Protocol, Informed Consent Document, associated plans and manuals. 3. Ensuring the conduct of clinical trials as per applicable guidelines, SOPs and protocols 4. Responsible for planning, conducting and reporting of audits pertaining to study. 5. Conduct of facility audits for its compliance and for ensuring CAPA implementation 6. Conduct of site audits and TMF audits as per study protocol, to gen...
Posted 3 days ago
2.0 - 5.0 years
2 - 4 Lacs
hyderabad
Work from Office
Role & responsibilities Review of Formulation development documents, Review of MFC/MPC, PDR and scale up related documents. Review of Formulation laboratory compliance. Review of Quality Management system. Must have knowledge on Product development activities
Posted 4 days ago
2.0 - 7.0 years
3 - 8 Lacs
bhiwadi
Work from Office
SRL Pharma R&D Centre urgently required below mentioned profiles with Exp. 2 - 6 Yrs. DQA - Development Quality Assurance - 2 Post Analytical R&D - 4 Post API R&D - 4 Post Please share profile on hr@shivalikrasayan.com, uday@shivalikrasayan.com Required Candidate profile Pharma R&D experience must in DQA, Analytical & API R&D (M.Sc.) Preparation of Pharmaceutical Development report Ready to relocate Bhiwadi, Rajasthan Ready to join Immediately Prefer Team Player Perks and benefits Best of Industries Salary based on Experience
Posted 2 weeks ago
3.0 - 8.0 years
4 - 8 Lacs
hyderabad
Work from Office
Walk-In Drive for Development Quality Assurance - Formulation Department @ MSN R&D Center Pashamylaram on 20.09.2025 (Saturday ) Roles & Responsibilities 1. Issuing of Batch Manufacturing Records, Analytical Raw datas and maintaining the respective log books. 2. Issuing of registers and formats for all departments and maintaining of records for issuance and reconciliation. 3. Issuance approval, Issuance and Retrieval of the documents in eDMS. 4. Receiving, Issuing and reviewing the bio batches related executed Batch Manufacturing Records, Analytical raw datas and archiving. 5. Responsible for review of product development documents and analytical documents related to technology transfer. 6. ...
Posted 1 month ago
9.0 - 13.0 years
6 - 9 Lacs
bhiwadi
Work from Office
Role & responsibilities 1. Investigation & handling of stability related OOS/OOT. 2. Handling of Stability Chamber Management. 3. Review of analytical data related to stability. 4. Review and approval of stability summary reports for the Dossier submission. 5. Preparation and Review of stability protocol and report. 6. Approval of SOPs in DMS. 7. Evaluation of stability data, require for dossier submission. 8. Timely compilation of stability summary report Skills and Competencies: Strong knowledge of GMP, GLP, SOPs, and regulatory requirements. Excellent analytical and problem-solving skills. Strong attention to detail and organizational skills. Effective communication and interpersonal skil...
Posted 2 months ago
3.0 - 8.0 years
4 - 8 Lacs
Hyderabad
Work from Office
Walk-In Drive for Development Quality Assurance - Formulation Department @ MSN R&D Center Pashamylaram on 02.08.2025 (Saturday ) Roles & Responsibilities 1. Issuing of Batch Manufacturing Records, Analytical Raw datas and maintaining the respective log books. 2. Issuing of registers and formats for all departments and maintaining of records for issuance and reconciliation. 3. Issuance approval, Issuance and Retrieval of the documents in eDMS. 4. Receiving, Issuing and reviewing the bio batches related executed Batch Manufacturing Records, Analytical raw datas and archiving. 5. Responsible for review of product development documents and analytical documents related to technology transfer. 6. ...
Posted 3 months ago
7.0 - 10.0 years
10 - 14 Lacs
Chengalpattu
Work from Office
1. Ensure QA oversight in product development lifecycle from pre-formulation to tech transfer 2.Review & approval of developmental protocols, reports & technical document 3. Readiness for audits and regulatory submissions - EU, USFDA, TGA Required Candidate profile 1. Work Location is Chengalpet 2. Qualified M.Pharm / M.Sc / B.Pharm 3. Minimum Exp of 7 to 10 yrs (in a DQA/QA role with pharma formulation R&D)
Posted 3 months ago
15.0 - 24.0 years
30 - 40 Lacs
Pune
Work from Office
Role & responsibilities To ensure API regulatory activities are as per stipulated time schedule and timely readiness of API regulatory documents / DMFs for new submissions / updates. To provide the necessary regulatory support/ advice/ guidance to the concerned API Manufacturing sites/ R & T Unit. To assure the quality of DMF, its submission and maintenance of submitted DMFs and updation on DMFs taking into consideration company Intermediates business. To co- ordinate and collaborate with QA/ QC/ Production/ Development department Preferred candidate profile M.Sc. Organic / Analytical Chemistry Full time with 15-25 years experience
Posted 3 months ago
5.0 - 10.0 years
5 - 9 Lacs
Sanand, Bavla, Ahmedabad
Work from Office
M.Sc. - Organic Chemistry with 5 to 8 years of experience in Pharma Manufacturing Industries. Having Pharma Company experience in APIs & their Intermediates. Literature Search via Scifinder, chemical abstract, Free Patent online & Journals. Required Candidate profile Communication with IPR & Regulatory Affairs & DQA Dept. Development with Extraction, Purification & Distillation of product. Preparation of Process safety report & data analysis of Intermediate & APIs Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 3 months ago
2.0 - 7.0 years
2 - 6 Lacs
Hyderabad
Work from Office
Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation DQA Department Development Quality Assurance / Formulation Quality Assurance R&D: Handling of QMS documents and Ensure the SOP compliance Review of Formulation Analytical Development Documents & Formulation Product Development Documents. Method Validation and Transfer Protocols and Reports Product development with QbD approach Responsible for ensuring GMP/GLP/GDP compliance in the Formulation and Analytical areas as per the respective SOPs. Review of FRD activities (LNBs, BDR’s, PDR’s, MFR’s and MPR’) SOP’s and Guidelines Preparation and Review and Approval of SOP’s. Responsible for conducti...
Posted 3 months ago
10.0 - 15.0 years
11 - 15 Lacs
Navi Mumbai
Work from Office
Role & responsibilities 1. SOP establishment, implementation of system process, note books, work books, protocols for testing and continuous monitoring of Quality Systems in R & D and ADL of Titan Laboratories and Titan Pharma Plus at various locations through SOPs and periodic inspections. 2. Documentation review , approval , Issuance, archival and control of all documents in R&D and ADL of Titan Laboratories and Titan Pharma Plus at various locations . Example Review and approval of MFR against the lab note books , specifications , MOA against analytical method validations , review of analytical method validation protocol and report. Review of ADL results against raw data. Calibration proc...
Posted 4 months ago
2.0 - 5.0 years
3 - 7 Lacs
Hyderabad
Work from Office
Hi, Greetings from Biophore !! We are hiring for QA department - API. Experience: 2-5 Years Job Location : R&D Center, Pashamylaram . Please go thorough the JD . Should aware of SER Report (Structure Elucidation Report ) Should aware of COA Preparation and Review Interested candidates please share your CV's to "recruitments@biophore.com"
Posted 5 months ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation DQA- Department . Position :Executive or Sr Executive Experience : 2 - 8 Yrs Job Description: 1) Handling of QMS documents like Incident, change control and LER. 2) Review of Formulation Analytical Development & Method Validation and Transfer Protocols and Reports. 3) Review of Product development with QbD approach. 4) Review of FRD Documents (LNBs, BDRs, PDRs, MFRs and MPR) 5) Preparation and Review and Approval of SOPs ,Guidelines. Responsible for conducting Internal Audits/External Audits for Cross functional Departments.Responsible for Review and Approval of Vendor Qualification Please S...
Posted 5 months ago
12.0 - 20.0 years
15 - 25 Lacs
Thane, Navi Mumbai, Mumbai (All Areas)
Work from Office
Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top manag...
Posted 5 months ago
3.0 - 6.0 years
5 - 9 Lacs
Medak
Work from Office
Key Roles & Responsibilities:1. Oversee and support the overall activities during the product development life cycle from quality perspective in R&D (API and intermediates). 2. To understand the site needs with respect to system establishment and sustainability. 3. Author/ Review and approve the SOPs/work directions required for implementing the Quality systems in R&D activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions. 4. Review and approve Lab Familiarization Reports (LFR), Product development reports (PDR), Technology transfer, product specifications & STPs, analytical method validation, method transfer, qualification, calibration, p...
Posted 5 months ago
3.0 - 8.0 years
3 - 6 Lacs
Bharuch, Ankleshwar
Work from Office
Review the Lab validation Protocol and Report of CRD Review of Process Development report for DMF filing. Required Candidate profile Lead the DQA department to implement CGMP rules and regulations in Research & Development.
Posted 5 months ago
4 - 7 years
4 - 6 Lacs
Hyderabad
Work from Office
Dear Respect Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation QA Department Job description -4 -7 Yrs Development Quality Assurance / Formulation Quality Assurance R&D: Handling of QMS documents and Ensure the SOP compliance Review of Formulation Analytical Development Documents & Formulation Product Development Documents. Method Validation and Transfer Protocols and Reports Product development with QbD approach Responsible for ensuring GMP/GLP/GDP compliance in the Formulation and Analytical areas as per the respective SOPs. Review of FRD activities (LNBs,BDRs, PDRs, MFRs and MPR) SOP’s and Guidelines Preparation and Review and Approval of SOP...
Posted 5 months ago
2 - 4 years
4 - 6 Lacs
Hyderabad
Work from Office
Role & responsibilities Review of Analytical method validation, method transfer and method verification protocols & reports. Review of method development reports. Review of Stability & Holding Study analysis data. Review of equipment qualification /calibration/ validation reports (IQ, OQ, PQ) related to all analytical instruments. Should have knowledge on review of Specifications & Standard test procedures. Review of reference standard and impurity COAs and characterization data. Should have knowledge of GTI & Nitrosamines risk assessment. Responsible for issuance and archival of documents. Should have good knowledge of ICH guidelines, USP general chapters. Should have knowledge of QMS activ...
Posted 6 months ago
3.0 - 6.0 years
0 - 3 Lacs
hyderabad
Work from Office
1. To review/approve method development documents, specifications (FP/IP/RM/PM), test methods (FP/IP/RM/PM), method validation documents, method transfer documents, stability reports, certificate of analysis and any other analytical related documents. 2. To review and approve instrument qualification documents, calibrations documents, preventive maintenance documents, training planners, AMC planners. To ensure calibrations, preventive maintenance, AMC and trainings as per planners. 3. To prepare, review, approve, revise and control standard operating procedures and documents. 4. To handle change controls, incidents, deviations, corrective and preventive actions (CAPA), out of specifications ...
Posted Date not available
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