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5.0 - 6.0 years
4 - 6 Lacs
Gangtok, Rangpo
Work from Office
Preferred candidate profile Qualification : B Pharma/M Pharma Year of Experience : 5 - 6 Yrs in shop floor management. Must have hands on experience in Granulation Section. Having exposure of Audit facing internal and external party. Interested candidates may share profile at hr.plant@zuventus.com Job Location : Sikkim
Posted 1 month ago
3.0 - 6.0 years
10 - 20 Lacs
Hyderabad
Work from Office
Key Responsibilities: Search and review scientific information / literature Drafting, submitting applications with all necessary information to RA for related Licenses required for Product Development. Identify and propose formulation strategy for product development. Read, discuss and plan Developmental activities, bring Innovation in work and adopting Digital Initiatives while doing scientific work. Visualize the developmental needs of the product. Work along with Cross functional team towards to meet project milestones as per timelines. Use Scientific approach to mitigate challenges during development, scale up and Technology transfer of the product. Qualification M.Pharm/Phd(Pharmaceutics): Experience- 2-6 years Additional Information
Posted 2 months ago
4.0 - 9.0 years
4 - 7 Lacs
Gangtok
Work from Office
Process Mechanical, Process Electrical, HVAC, Water System with WFI Knowledge, Utility Electrical (Chiller, DG, Air compressor, Heat pump, Boiler)
Posted 2 months ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Walk In Drive For Production OSD In Formulation Division @ Vizag Department:- Production OSD Qualification :-ITI | BA | Diploma | B Com | BSC | B Pharmacy Experience :- 2 To 8 Years Skills :- Blister Packing | CAM & HI Cartonator | Blister CAM | Cartonatory | Capsule Filling | Roll Compactor | Compression | Coating | Granulation | Documentation | Packing Executive | Manufacturing Executive Division :- Formulation Interview Date:- 08-06-2025 Interview Time :- 9.00AM TO 2.00PM Venue Location:- Hotel Cygnett Inn Ramachandra , 31-2-4/5, NH16, opp. All India Radio Station, Kurmannapalem, Visakhapatnam, Andhra Pradesh 530046 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Coating , Granulation , Compression, Capsule Filling , Blister Packing , Cam Cartontor, Hi Cartonator, Primary Packing , Secondary Packing, Documentation. About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
Posted 2 months ago
8.0 - 12.0 years
9 - 12 Lacs
Thane, Mumbai (All Areas)
Work from Office
Role & responsibilities To lead the OSD department team and ensure manufacturing process development and Optimization as per the regulatory requirements & technology transfer of the projects in co-ordination with Production and planning department for regulatory & ROW products. Accountabilities and mandatory requirements: Ensure composition and manufacturing process development of new as well as established products and ability to improvise if needed. Ensure manufacturing process/new process within Budget for maximizing efficiencies of Formulation Department Lab. Guide group for day-to-day activities and informing Formulation Development Department (FRD) colleagues for the schedule and timelines for the product development as well as technology transfer of Exhibit, Validation or commercial batches. Ensure group co-ordinate with other functions including Purchase, Production for the status of availability of Raw Materials, Packaging Materials required for development batches/ exhibit batches/ Validation batches at site. Ensure development and stability data generation of the new as well as trouble shooting products as per the regulatory or ROW market requirements. Guide to the for encounter the trouble shooting of legacy products and to provide the Technology transfer documents to resolve or to overcome issues related to the legacy products to provide quality products to the customer. Guide group for the smooth technology transfer of new as well as existing products or trouble shoot products for better to meet the finished product specification. Ensure the Regulatory queries to be addressed in time and guide the group leaders to work on to provide comments on the received quires to be close within provided timeline. Work closely with cross functional team for planning /execution of the Technology transfer/Exhibit/Validation batches of the individual projects to meet the timelines assigned. Provide the technical oversight (guidance), Plan, co-ordinate and oversee the work activities related to technology transfer/Exhibit batches/Validation batches of projects not limited to EU authorization but also CMO/ROW projects. Ensure Compilation of Development batches/Exhibit batches/validation batches data included with critical observations and submission of the same to R&D Head. Co-ordinate with production department for planning of tech transfer /Exhibit/Validation batches and execution/monitoring of the batches of the products starting from dispensing of the materials till packaging of the product to ensure smooth technology transfer of the products complying to the regulatory requirements. Preferred candidate profile- - 8-12 years of experience in Regulated market- OSD formulation & Development and technology transfer. - Good communication, open exchange of information and project teamwork will be required in order to meet the job performance. - Will be expected to accomplish his work assignments by interacting closely with scientific staff/Production staff and by developing the co-operative working relationships with other personnel within the company. - Must be able to work/co-ordinate with different functions within ALS and prioritize the workload to meet the predetermined timelines and need to work as a team with open communication, transparency and mutual trust. - Proper documentation pertaining to Formulation Development as per the Regulatory requirements and as per companys system.
Posted 2 months ago
2.0 - 6.0 years
2 - 3 Lacs
Pune
Work from Office
Role & responsibilities 1 Preparation of standard operating procedure with its annexure. 2 Preparation of Specification, standard test procedure of Raw Material, Packing Material, Finished product as per pharmacopeia and in-house methods. 3 Performing instrument qualification and calibration as per schedule. 4Sampling , analysis and review of raw water, purified water, raw material, packing material, finished product and in process sample, stability sample as per Specification with ERP entries 5 Preparation of COA of raw material, packing material, finished product and in process sample and stability study summary sheet ,trend analysis. 6 Maintenance of reference standard, primary standard and Preparation and maintenance of Working Standard. 7 Preparation and standardisation of Volumetric Solution and preparation of reagents. 8 Handling of all instruments and equipments in quality control. 9 Analysis of samples on HPLC,GC,IR and UV 10 Arrangement and maintenance of control sample and stability study sample 11 Sample send to public testing laboratory for analysis and coordination with laboratory for the same. 12 Monitoring the of chemicals and glassware received. 14 Monitoring the disposal of scrap, chemical and reagent waste and left over sample. 15 Calibration of Glassware 16 To follow the Good Documentation Practice and Good Laboratory Practice in the Laboratory. 17 To perform the analysis and Reporting of Water Validation, Method validation, Cleaning Validation and process validation 18 Any other task which is given to you by your senior in case of emergency. Knowledge Require 1. 2-5 years of experience in Formulation Pharmaceutical Plant. 2. Relevant Experience in Pharma formulation plant. 3. Computer proficiency in MS Office, Excel, e-mail and internet function
Posted 2 months ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Walk In Drive For Production OSD In Formulation Division @ Jadcherla Department:- Production OSD Qualification :-ITI| BA | Diploma |B Com | BSC | B Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 01-06-2025 Interview Time :- 9.00AM TO 2.00PM Venue Location:- ELITE HOTELS & RESORTSNH44,Bangalore Hyderabad Hwy Jadcherla, Telangana 509301 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Coating , Granulation , Compression, Capsule Filling , Blister Packing , Cam Cartontor, Hi Cartonator, Primary Packing , Secondary Packing, Documentation. About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
Posted 2 months ago
8.0 - 12.0 years
9 - 15 Lacs
Ahmedabad
Work from Office
Job Description: NDDS (Novel Drug Delivery System) Scientist - OSD will be responsible for designing, developing, and optimizing advanced drug delivery systems in oral solid dosage forms such as tablets, capsules, and controlled-release formulations. This role requires expertise in pharmaceutical formulation, process development, and a thorough understanding of regulatory requirements. Formulation Development: Design and develop NDDS formulations for oral solid dosage forms, including immediate release (IR), extended release (ER), and modified release (MR) products. Perform pre-formulation studies, including solubility, stability, and compatibility evaluations. Technology Integration: Implement innovative drug delivery technologies, such as microencapsulation, nano-particle systems, and multi-layer tablets. Optimize drug release profiles to enhance therapeutic efficacy and patient compliance. Process Development: Develop scalable and robust manufacturing processes for oral solid dosage forms. Perform critical parameter optimization for processes like granulation, blending, compression, and coating. Analytical and Stability Studies: Collaborate with the analytical team to develop and validate testing methods for NDDS products. Conduct stability studies in compliance with ICH guidelines. Regulatory Compliance and Documentation: Prepare technical reports, protocols, and batch manufacturing records. Ensure compliance with cGMP, ICH, and FDA guidelines during formulation and process development. Technology Transfer: Oversee the transfer of lab-scale formulations to pilot-scale and commercial manufacturing. Work closely with production, quality assurance, and regulatory teams to ensure seamless transfer. Innovation and Research: Stay updated with emerging trends in NDDS and oral solid dosage technologies. Contribute to patent applications and publications to support organizational innovation initiatives. Key Requirements: M. Pharm / M.S. in Pharmaceutics or related field. 4 to 7 years of relevant experience in formulation development of OSD for USFDA or other regulated markets. Strong knowledge of QbD, scale-up and technology transfer. Experience in developing formulations for bioequivalence studies and regulatory submissions. Familiarity with USFDA/EMEA regulatory guidelines and documentation. Excellent problem-solving, documentation, and communication skills. Preferred Skills: Hands-on experience with granulation, compression, coating, and capsule filling equipment. Ability to work cross-functionally in a fast-paced, deadline-driven environment.
Posted 2 months ago
2.0 - 6.0 years
2 - 2 Lacs
Hyderabad
Work from Office
Walk-in drive for Production OSD & Injectables Formulation @ Gandimaisamma. Departments :- Production OSD & Injectables - Formulations 1) Production OSD : Operators Blister Packing | CAM Cartonator | Blister CAM | Cartonatory | Capsule Filling | Roll Compactor | Compression | Coating | Granulation | Documentation | Packing Executive | Manufacturing Executive 2) Production Injectables : Operators LYO operator | Packing | Packing (Labelling) | Vial Filling & sealing | Compounding | QMS & Documentations | Autoclave | Aseptic processing area | Vial washing & Tunnel | Filling Experience :- 2 - 10 Years Qualification :- ITI | Diploma | BSc | B Teach | B Pharma | M Pharma | MSc Interview Date:- 01-06-2025 Sunday Interview Address:- MANJIRA HOTELS & RESORTS ( Elite ) NH44,Bangalore Hyderabad Hwy Jadcherla, Telangana 509301 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Payslips, Bank Statement, Certificates, Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
Posted 2 months ago
2.0 - 6.0 years
2 - 2 Lacs
Hyderabad
Work from Office
Walk-in drive for Production OSD & Injectables Formulation @ Gandimaisamma. Department :- Production OSD & Injectables - Formulations 1) Production OSD : Operators Blister Packing | CAM Cartonator | Blister CAM | Cartonatory | Capsule Filling | Roll Compactor | Compression | Coating | Granulation | Documentation | Packing Executive | Manufacturing Executive 2) Production Injectables : Operators LYO operator | Packing | Packing (Labelling) | Vial Filling & sealing | Compounding | QMS & Documentations | Autoclave | Aseptic processing area | Vial washing & Tunnel | Filling Experience :- 2 - 8 Years Qualification :- ITI | Diploma | BSc | B Teach | B Pharma | M Pharma | MSc Interview Date:- 01-06-2025 Sunday Interview Address:- Holy Child School, Near Dundigal Police Station, Gandimaisamma, Hyderabad Telangana-500043 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Payslips, Bank Statement, Certificates, Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
Posted 2 months ago
2.0 - 7.0 years
2 - 3 Lacs
New Delhi, Sonipat, Delhi / NCR
Work from Office
Quality control executive and quality assurance executive required for a pharma company at kundli, sonipat Qualification- B.pharma Exp- min 2 yrs salary- upto 25k Wtsapp me resume at 8295842337- MR. Bansal
Posted 2 months ago
12.0 - 20.0 years
12 - 16 Lacs
Aurangabad
Work from Office
We have been hired by a highly reputed and fast growing Pharma company to hire a "DGM - Formulation & Development' to be based at their plant located at Aurangabad . Details of the position are mentioned below: Role & responsibilities: Literature search/study and to prepare development trials strategies. Pre formulation study execution. Market/Innovator/reference product characterization. Execution and documentation of trial batches for prototype formulation development. Execution and monitoring of development stability studies. Execution of process optimization/scale-up batches. Technology transfer activities at site. Preparation/review of documents like BOM, MFR, compatibility study protocol & report, stability study protocol and report, PDR, etc as per requirements. Co-ordination with production, other relevant cross-functional departments/teams. Having experience/exposure of formulation development of solid oral, liquid, dry syrup, etc dosage forms aimed for ROW and domestic market. Should possess experience in handling various equipment like RMG, FBD/FBP, compression machine, roller compactor, coating machine, etc. Preferred candidate profile : Educational Qualification: M. Pharm Experience: 12 - 20 Years of relevant experience in a leading Pharma Company. Good Communication & Presentation skills Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak Director, Pharma Placements Inc. Mobile number: 98202 34987
Posted 2 months ago
1 - 4 years
2 - 4 Lacs
Ahmedabad
Work from Office
quality checks on raw materials, in-process, and finished product proper documentation as per GMP standard stability studies, sampling, and lab testing compliance with SOPs, regulatory, and safety guideline audits and assist in CAPA implementation
Posted 2 months ago
15 - 20 years
8 - 10 Lacs
Himachal Pradesh
Work from Office
Roles and Responsibilities Ensure compliance with GMP guidelines, BMRs, OSD requirements, and WHO standards for IPQA activities. Develop and implement effective quality control processes to ensure product quality and regulatory compliance. Conduct regular audits, inspections, and investigations to identify areas of improvement in batch manufacturing operations. Collaborate with cross-functional teams to resolve quality issues related to formulations, tablets, capsules, etc. Provide training on Good Manufacturing Practices (GMP) and other relevant regulations to employees.
Posted 2 months ago
3 - 8 years
3 - 8 Lacs
Ahmedabad
Work from Office
Role & responsibilities Candidate having experience in to OSD pharmaceuticals from QC/QA/Production/F&D/ADL
Posted 2 months ago
- 5 years
1 - 4 Lacs
Paonta Sahib, Chandigarh, Panchkula
Work from Office
Role & responsibilities We are seeking a diligent and experienced QA & QC & production. The successful candidate will Ensure that our products meet specified quality standards. This role involves managing both Quality Assurance ( QA ) and Quality Control (QC) processes, conducting inspections, and implementing improvements to maintain and enhance product quality. Expanding role in building a team of QA/QC executives. Salary Range: 15,000 to 25,000 (negotiable based on experience & skills) Experience: Minimum 2 years in QA/QC department of Tablet & Capsule or pharma manufacturing unit Preferred candidate profile Quality control analyst Responsible for testing and analyzing pharmaceutical products to ensure they meet established quality standards. They work in laboratories, using analytical Techniques to test raw materials, in-process samples, and finished products. Quality assurance analyst Responsible for ensuring compliance with regulatory requirements by conducting audits, inspections, and assessments Preferred candidate profile Qualification B.Pharma , B.Sc or B.Tech Biotech D.Pharma DIKSHA ( 8628944666 ) (9:30 AM to 7:30 PM ) Preferred candidate profile Company - Top Pharmaceuticals Companies based at Baddi HP. Fresher & Experience. Job Location- Chanigarh,Panchkula, Paonta Sahib ,BADDI ( Himachal Pradesh ) Functional : QC,QA & Production.Industry: Pharma manufacturing unit/ Food Technology The Saksham Success Enterprises Near Sunder Ayan by pass solan 173212 Himachal Pradesh Contact us DIKSHA ( 8628944666 ) (9:30 AM to 7:30 PM )
Posted 2 months ago
2 - 4 years
1 - 3 Lacs
Hyderabad
Work from Office
Key Responsibilities: Medication Dispensing: Accurately and efficiently dispense prescription medications to patients. Verify the accuracy of prescriptions and medication orders. Counsel patients on the use of their medications, including dosage, side effects, and potential interactions. Patient Interaction: Provide advice on over-the-counter medications and health products. Address patient questions and concerns regarding their medications. Ensure patients understand their medication regimens and adherence strategies. Medication Management: Monitor patient medication profiles to identify and resolve potential drug interactions or contraindications. Collaborate with healthcare providers to optimize medication therapy and patient outcomes. Maintain up-to-date knowledge of medications, treatment guidelines, and drug interactions. Compliance and Documentation: Adhere to federal and state regulations related to the dispensing of medications. Maintain accurate records of prescriptions, drug inventories, and patient interactions. Implement and uphold quality assurance processes to ensure safe medication practices. Pharmacy Operations: Manage pharmacy inventory, including ordering, stocking, and checking expiration dates of medications. Ensure the pharmacy environment is clean, organized, and compliant with health and safety standards. Participate in continuing education to stay current with advances in pharmacology and pharmacy practice. Collaboration and Communication: Work closely with other healthcare professionals, such as doctors and nurses, to support patient care. Participate in patient care team meetings and contribute to care planning. Educate patients and healthcare providers on medication-related issues.
Posted 2 months ago
15 - 20 years
13 - 17 Lacs
Mumbai, Boisar, Palghar
Work from Office
Role & responsibilities 1. Production Planning and Scheduling 2. Compliance and Documentation 3. Supervision of Manufacturing Processes 4. Personnel Management and Training 5. Quality and In-Process Control 7. Process Optimization and Yield Improvement 8. Regulatory and Customer Audits Preferred candidate profile Education: B.Pharm / M.Pharm / B.Sc with strong domain knowledge in OSD manufacturing. Experience: 15+ years in pharmaceutical production, with at least 5 years in a managerial role overseeing OSD manufacturing. Regulatory Exposure: Hands-on experience in facing WHO-GMP, and other inspections. Skills: Leadership, decision-making, analytical thinking, team management, and strong knowledge of GMP and QMS.
Posted 2 months ago
10 - 20 years
5 - 15 Lacs
Greater Noida
Work from Office
Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics and APIs, comprising Solid Dosage Formulations and Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research and Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it's a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R and D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL's full-fledged Regulatory Affairs and IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization.
Posted 2 months ago
15 - 24 years
14 - 24 Lacs
Halol
Work from Office
Position : Section Head - Batch Release QA Functional Area: QA Reports to: QA Head Grade: G9B Department: Quality Location: Halol (OSD) POSITION SUMMARY Responsible for IPQA activity and strategy in line with Sun Pharma Compliance, Product Quality Management objectives and Regulatory requirements. Responsible for planning and arranging for internal and external departmental support of quality assurance activities as directed in approved protocols, quality systems or Procedures. Identify and implement solution for improving existing site quality assurance systems and processes Involvement in co-ordination of activities for software like SAP HANA at plant Responsible for review and Approval of Quality management/GMP records. Responsible to ensure and perform site data review of batch records for completeness of documentation, approval and rejection of materials per current good manufacturing procedures and escalation of quality incidences, Continuous process verification (CPV). Manage the batch release function at site wrt documentation, systems, approval and rejection of materials, products at the Site per current Good Manufacturing Practices requirements. The incumbent will assure individual compliance with the all concerned regulatory requirements, GxPs and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures. Key responsibilities: 1. Ensure compliance to regulatory requirements on product, process, equipment and release procedures. 2. Manage Batch release activities for commercial dispatch. 3. Escalate compliance concern to concern stakeholder. 4. Review, compliance of BPR and batch release for commercial dispatch. 5. Review and approve the investigations, CAPA, and effectiveness checks with adherence to timeline. 6. Execute change control and risk assessment whenever required. 7. Ensure Quality Metrics, Quarterly BPR report as per specify timeline. 8. Ensure timely Batch release through electronic system. 9. Planning and arranging for internal and external departmental support of Quality Assurance activities as directed in approved protocols, quality systems or Procedures. 10. Follow the EHS policy and maintain the compliance to GMP requirements. 11.Co-ordination with QPs and customers of different region for batch release. 12.Management of Technical agreement with QP and Customers. 13.Responsible for oversight in warehouse and BSR. 14.Management of retain sample storage , inspection and life cycle management. MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS M.sc / M. Pharm/ B. Pharm 15 years with work experience preferred. REQUIRED SUCCESS ATTRIBUTE Knowledge of GxPs, cGMP and other regulatory requirements. Planning and Prioritization Collaboration Accountability Compliance Customer Service orientation Secondary Success Attributes People Connect Attention to detail Emotional control Effective Communication & Problem solving WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Posted 2 months ago
2 - 5 years
4 - 8 Lacs
Mysuru
Work from Office
Roles and Responsibilities 1. Review of Technology data package and preparation of Gap analysis document. 2. Preparation of technology transfer protocol and report. 3. Co-ordination with FD for smooth Tech Transfer. 4. Monitoring of validation batches at production site. 5. Perform Feasibility trials, Product evaluation trials to understand critical process parameter for smooth transfer and process understanding. 6. Review of MPCR and protocol. 7. Planning for Execution of Process design, Process qualification batch. 8. Coordination with Production, Quality assurance, Quality control, Engineering, Regulatory Affairs, SCM and warehouse for the TT activities. 9. Should be part of handling deviation, change control and failure investigations. 10. Process manufacturing parameters for Qualification batches Vs Commercial batches. 11. Preparation and reviewing of intended batch documents for regulatory submission. 12. Trouble shooting of existing products and process improvement to increase output or to reduce processing time or to improve the quality of products.
Posted 2 months ago
1 - 6 years
0 - 3 Lacs
Bengaluru
Work from Office
Roles and Responsibilities Granulation: Operate and maintain granulation equipment (e.g., high shear mixers, fluid bed dryers). Perform wet and dry granulation processes, ensuring uniformity and consistency in batches. Monitor parameters like moisture content, particle size distribution, and granule flow properties. Compression: Operate tablet compression machines to produce solid dosage forms. Monitor compression parameters such as hardness, thickness, weight, and friability. Troubleshoot and adjust compression equipment to optimize production. Coating: Oversee the tablet and capsule coating processes, ensuring proper application of film coatings. Work with coating machines like pan coaters and fluid bed coaters. Monitor and control coating parameters such as spray rate, drying time, and temperature. Capsule Filling: Operate capsule filling machines to ensure accurate dosing of powder or pellets into capsules. Perform checks for capsule fill weight and ensure proper capsule sealing. Troubleshoot issues related to capsule filling, such as jammed capsules or weight discrepancies. General Responsibilities: Ensure all equipment is functioning properly and safely, adhering to preventive maintenance schedules. Maintain a clean and sterile environment in compliance with Good Manufacturing Practices (GMP). Perform in-process quality control checks to ensure that the products meet specifications. Document all activities, including batch records, machine logs, and quality checks in accordance with regulatory requirements. Collaborate with quality control and engineering teams to identify and resolve any production issues.onitor and control process parameters to ensure quality products meet specifications. Maintain accurate records of production data and perform routine maintenance tasks on equipment. Collaborate with team members to achieve daily targets and improve overall productivity. Ensure compliance with Good Manufacturing Practices (GMP) guidelines.
Posted 2 months ago
1 - 5 years
1 - 4 Lacs
Ahmedabad
Work from Office
compliance with GMP and quality policie Approve RM/PM vendors and conduct regular quality audit validation, qualification, and batch release. GMP training $ support factory-wide implementation. Manage change control, deviation, and QMS execution.
Posted 2 months ago
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