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0.0 years
13 - 14 Lacs
Baddi
Work from Office
Accountable for all the compliance regarding activities for production block (OSD). Handling change controls and performing investigations for Deviation, OOS/OOT, Market complaints regarding soft floor. Handling Track wise activities. Performing Risk assessments Preparation of documents like SOP, URS, Protocols, BMR/BPR. Co-ordinating with cross functional departments for validation, qualification studies and Effectiveness check for CAPA. Q
Posted 3 months ago
2.0 - 7.0 years
2 - 7 Lacs
Visakhapatnam, Hyderabad
Work from Office
Dear Candidates, Greetings from KEYBIZ DASHBOARDS, We are looking for Quality Assurance Executive & Sr.Executive injectables&OSD for one of our reputed pharmaceutical client, based at Hyderabad & Vizag location. Please find below openings list. 1.IPQA 2.QMS 3.AQA 4.Validation 5.Equipment Qualification 6.CSV 7.Market Complaints. The above positions we are looking for Hyderabad & Vizag locations, interested please share us updated cv to prasanthi@mydashboards.in or feel free to call on 6305391924 Thanks and Regards Prasanthi - Dashboards Team HR
Posted 3 months ago
13.0 - 14.0 years
16 - 18 Lacs
Vadodara
Work from Office
Job Title: Manager Job Grade: M2 Function: Corporate Quality Compliance Sub-function: Complaints Manager s Job Title: Senior Manager-1 Location: Vadodara Job Responsibilities Review of Product Quality Complaint Investigation Reports (US Market). Coordinate with other stakeholders involved in the complaint handling process. Monitor the progress of Filed Alert Reports, Recalls Product Quality Complaint closure. Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Providing the response letter to the complainant. Reconciliation of received market complaints. Areas of Responsibility Product Quality Complaints Management Travel E...
Posted 3 months ago
1.0 - 6.0 years
3 - 6 Lacs
Hyderabad
Work from Office
Roles and Responsibilities Conduct quality control tests on raw materials, intermediates, and finished products using techniques such as HPLC, GC, FP, IP, Stability studies. Ensure compliance with cGMP guidelines and maintain accurate records of testing results. Investigate market complaints and perform microbiological analysis to identify root causes. Develop and implement quality assurance procedures for OSD formulations. Collaborate with cross-functional teams to resolve issues related to dissolution testing.
Posted 3 months ago
9.0 - 13.0 years
35 - 40 Lacs
Vadodara
Work from Office
1. Characterization of RLD pack samples. 2. Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement. 3. Identification of new packaging material & new vendor development for packaging materials. 4. Mold development for primary packaging material & secondary packaging material & its validation. 5. Support to Regulatory team on ANDA s/NDA s filling for regulated market. 6. Coordination with NPI & planning team for launch of ANDA s/NDA s. 7. Preparation & revision of packaging material specification. 8. Preparation & review of MPC, FMEA, TA, DHF & AFMEA. 9. Preparation & review of Development Study protocol & report & execute the study. 10. ...
Posted 3 months ago
6 - 10 years
7 - 8 Lacs
Baddi
Work from Office
Job Description Position : Senior Executive Quality Assurance Section : Quality Assurance Grade/Band : 1C Qualification : M.Sc. /B. Pharm. Desirable Experience: 06 - 10 years Followings will be the responsibilities of the position holder: To ensure effective implementation of system and procedure as per cGMP, cGLP and other Regulatory requirements, and monitor its compliance in laboratory. To participate in investigation of laboratory error report, incidents, out of trend and out of specification results and review the investigation report. To handle & coordinate QMS through SolTRAQs. To ensure the effective implementation of QMS through SolTRAQs application system. To participate in investi...
Posted 4 months ago
5 - 10 years
6 - 8 Lacs
Bhiwadi
Work from Office
Job Description: 1.Handling of QMS related activities i.e., CAPA ,etc 2.Handling of Market Complaint with related investigation. 3.Preparation, review and implementation of SOPs. 4.Handling of Internal Audit and related activities. 5.Preparation and handling of Audit related activities. 6.Preparation of Audit Compliance Report. 7.Preparation of Documentation, i.e., COA, COO, MSDS, TD. 8.Calibration/Validation of Instruments.
Posted 4 months ago
5 - 6 years
5 - 6 Lacs
Baddi
Work from Office
Role & responsibilities To carry out investigations related to OOS, OOT, Incident and Extraneous Peaks to ensure their closure and implementation of CAPA. Responsible for execution of Regulatory Notification as per SOP. To ensure implementation of all proposed actions identified as a CAPA of investigations related to OOS, OOT, and incident. Review of investigation reports, hypothesis protocol and hypothesis reports related to OOS/OOT and Incidents. Co-ordination with R&D, Production, Central Cell, CQA and other responsible for investigations. To prepare and review Quality documents such as (but not limited to) protocols, reports, SOPs STPs Specification, Investigation. Preferred candidate pr...
Posted 4 months ago
8.0 - 10.0 years
6 - 8 Lacs
pune
Work from Office
Job Description Preparation & Review of SOP’s of QA system and review / approval of SOP’s of other departments. Review of master BMR/BPR of commercial and exhibit batches. Review of BMR / BPR, scale-up and placebo batches. Review of executed BMR/BPR of commercial and exhibit batches for batch release. Issuance, Retrieval & Destruction of SOP’s, STP, specification, BMR/BPR, annexures & other formats. Login and review of quality system documents such as Deviation and IPOOS. In-process Quality Assurance during Production / Packing activities. Sampling at different stages of manufacturing / packing as per the requirement (In-process, BU, CU, finished, control, QP, Hold Time & stability etc.) Rev...
Posted Date not available
4.0 - 6.0 years
4 - 5 Lacs
vadodara
Work from Office
Job description Should have sound knowledge of QMS System and Change Control, Deviation and CAPA Procedure. Review of Preventive maintenance & calibration of equipment and systems. Investigation and closure of all deviations, OOS and complaints
Posted Date not available
3.0 - 5.0 years
5 - 6 Lacs
bengaluru
Work from Office
Role & responsibilities Review of the executed manufacturing documentation at contractual partners and ensure its compliance with internal Quality Management System and applicable Regulatory Guidelines in cooperation with Quality Management at Krka. Reviewing the manufacturing documentation of pharmaceutical products and identifying potential errors or irregularities. Participates in investigation of deviations, complaints, unfavorable trends, and OOS results with contractual manufacturers. Participate in harmonization of applicable change controls. Takes part in organizing audits of our contractual partners in line with the audit plan and monitors its realization. Monitors the manufacturing...
Posted Date not available
2.0 - 7.0 years
2 - 7 Lacs
jhagadia
Work from Office
JD: 1) To be prepared document related to audit as per audit agenda. 2) Filled vendor questionnaires & prepared related documents. 3) Keeping record of key Customer. 4) To be prepared process validation protocol and report as per seniors guidance. 5) To be prepare cleaning validation protocol and report as per seniors guidance. 7) To be prepared master, controlled, uncontrolled, reference, obsolete & distribute documents as per SOPs and formats requirement. 8) To help the senior for preparation of CAPA according to audit report. 9) Issuance of Change control, OOS, deviation & other QMS formats whenever required from respective department and retained record in logbook. 10) To be prepared BPC...
Posted Date not available
7.0 - 12.0 years
6 - 14 Lacs
baddi
Work from Office
Key Responsibilities: 1. QMS Implementation & Oversight: Maintain and continually improve QMS elements such as deviation handling, change control, CAPA, OOS/OOT, risk assessments, and quality reviews . Ensure compliance with GMP, GAMP, ISO, ICH (Q9, Q10), and regulatory agency requirements (e.g., USFDA, MHRA, WHO, EU GMP) . 2. Deviation & CAPA Management: Investigate deviations in manufacturing, QC, and support areas. Perform root cause analysis (RCA) and drive timely and effective CAPA implementation. Monitor the closure timelines and effectiveness verification of CAPAs. 3. Change Control & Document Control: Evaluate and manage changes in equipment, facility, process, and documents. Review ...
Posted Date not available
6.0 - 12.0 years
8 - 14 Lacs
gangtok
Work from Office
Job Title: Senior Manager -I (Production) Business Unit: Sun Global Operations Job Grade G9A Location : Gangtok (Sikkim) At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Key responsibilities: Responsible for timely delivery of...
Posted Date not available
7.0 - 12.0 years
9 - 10 Lacs
bengaluru
Work from Office
ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma. Job Summary Serves as a Senior Executive role within Quality Assurance, and as a senior professional practitioner within the following areas of expertise. Handling of Market Complaints, Handling of Supplier Qualification and Management Nitrosamine assessment Lead/A...
Posted Date not available
12.0 - 15.0 years
20 - 25 Lacs
vadodara
Work from Office
Job Title: Senior Manager Packaging Development Business Unit: R&D1 Regulatory Affairs Job Grade G9B/G9A Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Job Description Lead the PMD graphic team for all mar...
Posted Date not available
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