242 Osd Jobs - Page 8

The EUCS_TOOLS_SCCM role involves working with relevant technologies, ensuring smooth operations, and contributing to business objectives. Responsibilities include analysis, development, implementation, and troubleshooting within the EUCS_TOOLS_SCCM domain.

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP Document and Reporting Compliance Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. You will oversee the application development process and ensure successful implementation. Roles & Responsibilities:- Expected to be an SME- Collaborate and manage the team to perform- Responsible for team decisions- Engage with multiple teams and contribute on key decisions- Provide solutions to problems for their immediate team and across multiple teams- Lead the application development process- Ensure compliance with document and reporting standards- Provide guidance and mentorship to team members Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP Document and Reporting Compliance- Strong understanding of compliance regulations- Experience in designing and implementing compliance solutions- Knowledge of SAP systems and reporting tools- Ability to analyze and interpret complex data Additional Information:- The candidate should have a minimum of 7.5 years of experience in SAP Document and Reporting Compliance- This position is based at our Mumbai office- A 15 years full-time education is required Qualification 15 years full time education

Job Description: We are seeking a highly motivated and experienced professional for our Formulation and Development team in the R&D department. The ideal candidate will have a strong background in formulating Solid Oral dosage forms (OSD), Liquid orals, Semi solid or Topicals and experience in product development, scale-up, and technology transfer . Key Responsibilities: Literature review and Patent search Preparation of master formula card, Qbd product development report & other protocols. Design and develop formulations for new and existing pharmaceutical products. Conduct pre-formulation studies and compatibility testing. Execute lab-scale and pilot-scale batch manufacturing. Coordinate with analytical, regulatory, and production teams for seamless development. Prepare technical documents including MFRs, PDRs, development reports, and protocols. Handle technology transfer to manufacturing sites. Troubleshoot formulation and process-related issues during scale-up and validation. Ensure compliance with regulatory and quality standards Desired Candidate Profile: 4 to 10 years of hands-on experience in formulation development in a regulated pharmaceutical environment. Experience in development of oral solid dosage forms or injectables preferred. Familiarity with QbD principles and regulatory requirements. Good documentation practices and communication skills. Ability to work independently and in a team environment. Interested Candidates, please share your cv to nazrin.rasheed@gracure.com

Experience in operating packing machinery for solid dosage forms Knowledge of GMP, GDP, and safety protocols Attention to detail and documentation accuracy Ability to troubleshoot minor mechanical issues Basic understanding of pharmaceutical regulatory compliance Blister packing Strip packing Bottle filling and labeling lines Preferred candidates who can join on immediately

Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role : Microbiology analysis (Bioburden, MLT, Test for specified organisms, BET analysis) Chemical analysis for water samples Environmental Monitoring Utility Monitoring Water sampling Microbiology lab maintenance Role Accountabilities Responsible for Sample receipt of raw materials, in process, finished product and stability samples. Responsible for Microbiological analysis, Bacterial Endotoxin Test and Chemical analysis of different grades of water (PW/WFI/POW) as per the respective specification. Responsible for sample management and coordination with team for smooth operation of samples release activity. Responsible to perform the Bioburden and Microbial Limit Test. Responsible to perform the Method verification activity for BET, MLT and Bioburden test. Responsible for environmental monitoring of clean rooms in Microbiology laboratory. Responsible for all microbiological related activities like Media receipt, Media stock maintenance, Preparation of media, Sterilization, Growth Promotion for media, Culture maintenance and Media Disposal. Monitoring and review of Temperature monitoring data record of equipment and clean room. Monitoring of differential pressure in QC Microbiology Laboratory. Responsible for disinfectant preparation, cleaning, and fumigation of microbiology laboratory. Follow the required EHSS policies and Good hygiene practice. Undertake other responsibilities related to Microbiology as per requirement. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Accountabilities as a Syngene Leader (only for Leadership Hires) Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities. Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance. Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority. Specific requirements for this role Experience : 1-2 YEARS Skills and Capabilities Microbial analysis of water, OSD products, Injectable products, Environmental monitoring Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team Good speaking-listening-writing skills, attention to details, proactive self-starter Ability to work successfully in a dynamic, ambiguous environment Ability to meet tight deadlines and prioritize workloads Ability to develop new ideas and creative solutions Should be able to work in team and flexible for working in shifts Should be a focused employee Good documentation capability Education : M.Sc. Microbiology Equal Opportunity Employer .

Role & responsibilities SCCM Admin L2 with OSD 5+ Years & Only Male candidates- Immediate Joiners Preferred candidate profile

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.

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.

Job Role : Sr.Manager Production (Granulation) Responsibilities : Shop floor activities of Granulation Department. Complying with internally designed management system such as shift log books, daily reports etc. Complying with approved GMP practices such as uniform, entry/exit procedure etc Maintaining hygiene and sanitation practices. Man power distribution in the department Performing and maintaining record for the performance check of balance and Halogen Moisture Analyzer. Authorization of BMR/BPR after checking BMR/BPR as approved production chemis Execution of Manufacturing process as per the laid down procedure and maintaining documents for the same Maintaining records of Machine Sequential log. Training to the workmen regarding safety/hygiene & cGMP To prepare the monthly report and maintaining WIP Status. To review and approve qualification protocol. To Review of filled BMR. To co-ordinate with IT for User rights management of new and existing employees in computers and equipment. Tracking and responsible for retrieval of a format of the department printed through Documentum Software . To generate MIO through SAP. Preparation of BOM, PR, PO, GIM, and all other SAP transaction for production. To initiate, review and approval of QMS document

Analytical Development Laboratory Position: Executive Experience: 3-8 years Qualification: M.Sc. / M.Pharm. Job Responsibilities: HPLC/GC/IC method development, feasibility, verification, equivalency, validation of API for complex OSD products, oncology products, topical products having exposure to regulated, Semi Regulated & India markets Comparative evaluation of methods with alternative vendor methods versus existing primary vendor and regulatory impact analysis Dissolution development, comparative dissolution, multimedia dissolution and statistical evaluation and report preparation Good understanding and hands on experience of analytical instruments like HPLC, IC, GC etc. NI/GI & NDSRI' with LCMS/GCMS expertise, Solid state characterization and API sameness study Hands on experience on In-vitro Studies, E&L, Solid State characterization, IVPT/IVRT, Impurity characterization, sameness study Well versed with USP/EP/BP/JP and various current regulatory guidelines (ICH/EMEA/FDA) Perform maintenance and calibration of lab instruments / equipment. Formulation & Development Position: Executive Experience: 3-8 years Qualification: M.Pharm. Job Responsibilities: OSD, Oncology, Alternative vendor development, Exposure of Regulated, Semi Regulated & India Markets FnD Documents like Specifications, MFC,BMR, Stability protocol, CCF , Deviation etc. (For FnD doc cell), Knowledge of SAP, loading of Specification in SAP, BOM loading, Stock overview, PR generation etc.

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

Role & responsibilities : Candidate should have experience in Primary/Secondary packing Key Skills: Bottle Packing CVC/Dry Syrup Packing Must have skills on Primary/Secondary are equipment operation and cleaning operation Trouble Shooting in CVC Bottle packing (Secondary) Key Skills: Blister Packing BQS & Elmach CAM & IC150 Cartonator (Automatic Machine) Track & Trace Work Location : UNIT V Jadcherla (80 km far from the Hyderabad) Interested one share there resume to : sharadha.b@hetero.com Contact Number: 9100408534/8121003471

Provide strong leadership Lead CMO Quality operations for India CMO and US CMO. India CMO includes QA oversight for all contract mfg. sites based in India and engaged in mfg. SUN products for India, ROW, EM markets through various business model like LL, P2P, In-licensing. US CMO includes QA oversight for all contract mfg. sites based in India and engaged in mfg. SUN products for US market through various business model like LL. Essential Job Functions: 1. To ensure availability and periodic revision of quality agreements (QAg) between SUN Pharma CMO sites. 2. To ensure product quality complaints, quality alerts, FAR, recalls etc are being handled timely and inline with QAg. 3. To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities requirements are met and CMOs maintain and improve the adequate level of compliance, through CMO oversight. 4. Proactively assess quality issues and ensure compliance to QA/QC regulatory requirements in manufacturing operations at CMO sites. 5. Prevent Quality or regulatory non-compliance which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the quality, financial performance and reputation of the company. Ensure that Non-compliance are to be addressed via robust investigation corrective and preventive actions (CAPA). 6. Accountable for implementing and ensuring compliance to applicable Global SOPs, Policies, Standards and Quality systems at CMO oversight function. 7. Responsible for CMO Quality functions lean design and execution of continuous Quality Compliance improvement initiatives, standardizations and efficiency gains to enhance compliance and drive efficiencies. 8. Facilitate new product launch and technology transfer activities (Sun site RD) and ensure timely execution of related activities. 9. Drive annual risk assessment of CMO sites (India and US market), review the outcome, identify high risk sites/products and ensure remediation plan is in place either by de-risking of manufacturing sites or product manufactured therein. 10. Responsible for leading, directing, identifying and setting quality goals, objectives, and perfect execution in alignment with Global Quality Goals at CMO oversight function. 11. Responsible for ensuring smooth collaboration with Sun sites, commercial, RA, RD, MSTG, corporate quality audit CMO sites for activities related to product manufacturing, release and other quality technical issues to leverage synergies. 12. Monitor and utilize industry trends, internal learnings and new regulatory requirements to Identify and upgrade quality management system, facility and processes to ensure compliance at CMO sites as applicable. 13. Coach and develop direct and indirect reports, as appropriate, through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities. 14. Periodic visit of high risk CMO sites to ensure quality and compliance of the sites. 15. Will perform other work-related duties, as required. Requirements and Qualifications: Basic Qualification: M.Sc./ B. Pharm / M. Pharm or equivalent. Industrial Experience Knowledge: Total 22-25 years of experience in Production, Quality Assurance, Quality and compliance in OSD and / or sterile formulations manufacturing. Exposure to various formulations like sterile, ophthalmic, aerosols, Creams, Ointments, Oral Liquids, Nutraceutical, capsules (Hard and Soft Gelatin) and tablets will be preferred. Knowledge of GMP s in FDA, Domestic and international regulatory environments. In-depth knowledge of FDA guidance s such as ICH is must. Strong organizational, interpersonal and communication skills. Ability to work effectively in multicultural matrix organization.

03 - 06 years experience of external preparations, Ointment and OSD IPQA activities Job Responsibilities - - Totrack batches for process validation, packing validation and hold time study. Certificationof Appropriate and timely Line-Clearance for Manufacturing, Packing, Dispensing Tocarry out the online checks& to take on line SAP entries. - ToWithdraw & Submit the Samples (Analysis SFG and FG & Control samples,Validation, Regulatory, R&D, Hold time study & Micro samples) toConcern Dept. as & when required. - Toensure the cGMP on the shop floor and to highlightthe on line Problems / Non Conformances with the respect to Procedures,Specifications, SOPs, cGMP etc. on day to day basis Numbers ofcritical/major nonconformance noticed. OnlineBPR, Logbooks completion & Review of documents like Preventive calibrationrecords, daily/weekly quarantineregister etc. in the Concerned dept. - Issuanceof Batch Manufacturing Records and Batch Packing Records to productiondepartment. - Reviewof Executed Batch Manufacturing Records and Batch Packing Records Toverify online finished goods before transfer to BSR.

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

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.

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.

RoleMedical Advisor Type Full Time Job description - Plan, collate, analyse, develop and execute medical initiatives in the portfolio. - Plan and execute the pre-launch and launch medical activities with impact measurement. - Develop omnichannel content and inputs for medico-marketing activities. - Co-create and roll out the disease awareness initiatives and engagement of digital KOLs. - Answering scientific queries of internal & external customers. - Support Global and local Data generation Studies. - Support and follow up on ISS. - Initiating and reviewing medical publications. - Review and approval of promotional materials and scientific content. - On field training of Regional Medical Affairs team. - Training of cross functional teams. - Conduct Face to face meetings. - Execute KOL briefing plans for medico-marketing activities. - Support Global and Local Investigator meetings. This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Position: Senior Manager Sub-function: Global Actions Management Function: Corporate Quality Compliance Sub-function: Global Actions Management Function Head Title: Sr. General Manager Location: Vadodara Areas of Responsibility Ensure assessment of Regulatory inspection citations identified at Sunpharma sites to derive the global action Ensure assessment of 483s, warning letter issued to other organization by USFDA to derive the global action Ensure assessment of internal learning (such as Quality alert) to derive the global action Preparation of Global action based, following are the sub-activities: v. Review of the regulatory guidance related to the topic vi. Review of existing site practices vii. Drafting of Global action recommendations viii. Preparation of reference procedures and associated formats for Global action implementation as applicable ix. Finalization of Global action recommendation post review with Global action committee and relevant stakeholders Ensure issuance and approving of Global actions in Trackwise. Coordinating with sites for the implementation of Global action recommendations Ensure review of site action closure for completeness and correctness Ensure closure of global action upon completion of all issued site action records of a global action Ensure circulation of Global action status to relevant stakeholders Ensure compliance calls being executed as per pre-defined agenda i. e. internal and external learnings being shared and explained with stakeholders. o Ensure identified gaps being shared across sites and tracked for implementation Ensure maintenance of database for regulatory inspections at SUN Pharma Review of draft response of inspection observation Ensure Sun site regulatory inspection observations trend is in place for meaningful analysis All other duties as assigned by Head Corporate Quality Compliance and CQA Travel Estimate Approximate 30% Job Requirements Educational Qualification M. SC / M. Pharm Specific Certification Not specific Skills Quality Management System, Compliance, CAPA, Investigations, Audit Management, Supplier Qualification, Change Management, Manufacturing and Engineering Assurance (OSD and Sterile) Experience Minimum 15 years

Role & responsibilities 1) Candidate should have understanding and experience in development of different types of oral dosage forms like immediate release formulation/delayed release formulations/ pellet coating and controlled release formulation,hard gelatin capsule, soft gelatin capsules, solutions, suspensions, dry powders and syrups for different Regulated and semi regulated markets. 2) Carry out pre-formulation and formulation development experiments for new chemical entities and ANDA formulations. 3) Develop new technology platforms and conduct feasibility studies for novel formulations such as microspheres, pellets, and spherules, aqueous and non-aqueous suspensions, ophthalmic and spray coated particles using various polymers. This includes preparation of prototype formulations for bio/clinical studies, analyzing experimental data and preparation of technical reports. Follow existing or prepare new SOPs and equipment operating procedures. 4) Design, develop and conduct appropriate dissolution studies for the novel dosage forms. Prepare stability protocols and collect the stability data. As per ICH guidelines, set specifications for raw materials and finished products. Organize tech transfer of developed products to plants for the manufacturing of scale up, exhibit, clinical or bio study batches. Review bio study and clinical study designs and protocols. Support clinical supply manufacturing and labeling activities along with drug supply inventory control and reconciliation. 5) Maintain inventory and reconciliation of Innovator products. Maintenance and up keeping of the lab and pilot areas. Give timely support in resolving regulatory queries. 6) Analyze and interpret significance of bio/clinical study results. Preparation and review of registration lot documents, technical reports and submission related documents in accordance with the applicable FDA and ICH guidelines such as CMC and CTD sections of IND, 505(b)2, NDA and Para III and IV certified ANDA. Interact with QC, QA, Regulatory, Marketing, Clinical, Purchasing and Commercial departments for the successful development of new products. Maintain and follow safety standards as issued by the Company.

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

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

ASTER DM HEALTHCARE LIMITED is looking for Senior Specialist Radiology & Imaging Sciences to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes

Role Purpose The purpose of the role is to resolve, maintain and manage client’s software/ hardware/ network based on the service requests raised from the end-user as per the defined SLA’s ensuring client satisfaction Do Ensure timely response of all the tickets raised by the client end user Service requests solutioning by maintaining quality parameters Act as a custodian of client’s network/ server/ system/ storage/ platform/ infrastructure and other equipment’s to keep track of each of their proper functioning and upkeep Keep a check on the number of tickets raised (dial home/ email/ chat/ IMS), ensuring right solutioning as per the defined resolution timeframe Perform root cause analysis of the tickets raised and create an action plan to resolve the problem to ensure right client satisfaction Provide an acceptance and immediate resolution to the high priority tickets/ service Installing and configuring software/ hardware requirements based on service requests 100% adherence to timeliness as per the priority of each issue, to manage client expectations and ensure zero escalations Provide application/ user access as per client requirements and requests to ensure timely solutioning Track all the tickets from acceptance to resolution stage as per the resolution time defined by the customer Maintain timely backup of important data/ logs and management resources to ensure the solution is of acceptable quality to maintain client satisfaction Coordinate with on-site team for complex problem resolution and ensure timely client servicing Review the log which Chat BOTS gather and ensure all the service requests/ issues are resolved in a timely manner Deliver NoPerformance ParameterMeasure1. 100% adherence to SLA/ timelines Multiple cases of red time Zero customer escalation Client appreciation emails Mandatory Skills: Desktop Imaging. Experience3-5 Years.

Role Purpose The purpose of the role is to resolve, maintain and manage client’s software/ hardware/ network based on the service requests raised from the end-user as per the defined SLA’s ensuring client satisfaction Do Ensure timely response of all the tickets raised by the client end user Service requests solutioning by maintaining quality parameters Act as a custodian of client’s network/ server/ system/ storage/ platform/ infrastructure and other equipment’s to keep track of each of their proper functioning and upkeep Keep a check on the number of tickets raised (dial home/ email/ chat/ IMS), ensuring right solutioning as per the defined resolution timeframe Perform root cause analysis of the tickets raised and create an action plan to resolve the problem to ensure right client satisfaction Provide an acceptance and immediate resolution to the high priority tickets/ service Installing and configuring software/ hardware requirements based on service requests 100% adherence to timeliness as per the priority of each issue, to manage client expectations and ensure zero escalations Provide application/ user access as per client requirements and requests to ensure timely solutioning Track all the tickets from acceptance to resolution stage as per the resolution time defined by the customer Maintain timely backup of important data/ logs and management resources to ensure the solution is of acceptable quality to maintain client satisfaction Coordinate with on-site team for complex problem resolution and ensure timely client servicing Review the log which Chat BOTS gather and ensure all the service requests/ issues are resolved in a timely manner Deliver NoPerformance ParameterMeasure1. 100% adherence to SLA/ timelines Multiple cases of red time Zero customer escalation Client appreciation emails Mandatory Skills: Software Distribution & Patch management. Experience3-5 Years.