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11 Job openings at Gufic Group
About Gufic Group

Gufic Group is a leading Indian pharmaceutical company that develops, manufactures, and markets pharmaceutical products, specialized in biotechnology and biosimilars.

Quality Control (Officer/ Sr. Officer/Executive)

Navsari

2 - 6 years

INR 2.0 - 5.0 Lacs P.A.

Work from Office

Full Time

Roles and Responsibilities Responsible for Analytical Method Validation. Responsible for HPLC/GC instrument handling. Responsible for Daily review of Analytical balance and Daily Temperature monitoring. Responsible to follow analytical procedures and generate online raw data. Responsible for Stability Studies and Analysis. Responsible to operate and analyze of raw materials, In Process, cleaning samples, samples for vendor qualification, Stability samples, standard and Finish product Samples and instrumental method (HPLC / UPLC / GC) and to perform analysis of process validation. Responsible for Daily verification of analytical balance and daily temperature monitoring. Online entry in logbooks of instrument, column, working standard, chemical inventory whenever use. Responsible for in process data review in night shift. Finished product sample receive, entry taken in register and maintain daily status. Responsible to follow all the Standard operating procedures, to give Instructions for housekeeping, cleaning and maintaining the laboratory area. Responsible to follow all the analytical procedures and generates online raw data, Chromatograms, calculation sheets and charts with reviewer signature. Responsible to control and maintain records like protocols, Specification, Standard test procedure, Analytical work record, Standard operation procedure, In- process analysis records, usage log books and status labels during day to day Analysis. Responsible to perform calibration and maintain its records. Responsible to Prepare and maintain record of finished product. Responsible to maintain record of chemicals, glass wares and other lab items of department. Responsible for cleaning, maintenance, and daily calibration of specified instruments. Responsible to maintain records and qualification of primary standards, reference standards and working standards. Responsible for reporting to senior if any abnormality observed during analysis and perform for the out of specification and to investigate the OOS (Out of specification) or OOT (Out of trend)if found and Responsible for maintaining QMS related documents. Responsible to follow various EHS (Environment Health and safety) guideline and use appropriate PPEs (Personal protective equipments) . . Desired Candidate Profile Candidate Should be from Pharma background Candidate Should have excellent knowledge of ICH Guidelines Prefer Who can work in a shift and willing to relocate in Navsari, Gujarat Candidate should have Work Accuracy.

Divisional Sales Manager - Neurocare

Kolkata

5 - 10 years

INR 8.0 - 15.0 Lacs P.A.

Remote

Full Time

Role & responsibilities Essential Duties and Responsibilities: Self To achieve primary and secondary sales targets and growth objectives assigned for his/her zone. Monitor and analyse performance metrics and suggest improvements on regular basis for his Zone. Prepare monthly, quarterly sales forecasts and chase it with meticulous planning and Account Management. Establish productive and professional relationships with key personnel in assigned customer accounts. Identify new potential customers and new market opportunities from his Zone. Forecasting accuracy for Sales and Inventory planning/control Responsible for his/her teams Collections/Management of accounts receivables. Participate in periodic sales review and suggest way-forward to surpass zonal revenue targets. Control attrition and build a motivated and committed sales team through a culture of achievement orientation, recognition and reward Create a pipe-line of future zonal leaders for his personal & teams professional growth. Team Lead different sales teams of his/her zone to surpass revenue targets. Develop and implement effective sales strategies for his zonal teams with the help of Brand promotion, Strategies Implementation and Execution effectively to achieve Zonal Budget also ensuring profit margin to organization. Support the team members in negotiating and closing agreements with large trade customers, corporate accounts and govt. institutions. Provide timely and effective solutions to the respective teams aligned with clients’ needs. Ensure implementation of CRM and KOL engagement plans by the zonal teams in conjunction with marketing and medical affairs team Develop a comprehensive sales and distribution strategy to maximise sales opportunities. Preferred candidate profile Should be a people’s person with Strong team building/ nurturing and mentoring capabilities. Should possess Professional manners and etiquettes. Self-motivated with a results-driven approach – excellent with negotiation skills. Enthusiastic with strong interpersonal skills. High achievement orientation Effective communication skills Effective analytical & Problem-solving Skills Should be learning Agile and passionate about sales. Good at using MS Office/ EXCEL.

Key Accounts Manager - Neurocare

Guwahati, Kolkata, Chandigarh

2 - 7 years

INR 3.5 - 8.5 Lacs P.A.

Work from Office

Full Time

To achieve primary and secondary sales targets and growth objectives assigned for his/her territory. Prepare monthly, quarterly sales forecasts and chase it with meticulous planning and Account Management. Establish productive and professional relationships with all the stake holders of his/her territory such as HCPs, Stockists, Pharmacies, Purchase department of different accounts and support staff of the account to name a few. Implement effective sales strategies for his territory under the guidance of the DSM and with the help of Brand promotion, Strategies Implementation and Execution effectively to achieve his territorys budget. Identify the key accounts for negotiation and closing the business agreements. Provide timely feedback and suggestions to the DSM on his/her territorys clients needs. Ensure implementation of CRM and KOL engagement plans in his/her territory in conjunction with marketing and medical affairs team. Identify new potential customers and new market opportunities from his territory. Accountable for his/her territory’s Collections/Management of accounts receivables. Prepare & participate in periodic sales review of his territory by the DSM and suggest way-forward to surpass his/her territory revenue targets.

Key Accounts Manager - Neurocare

Pune

2 - 7 years

INR 3.5 - 8.5 Lacs P.A.

Work from Office

Full Time

To achieve primary and secondary sales targets and growth objectives assigned for his/her territory. Prepare monthly, quarterly sales forecasts and chase it with meticulous planning and Account Management. Establish productive and professional relationships with all the stake holders of his/her territory such as HCPs, Stockists, Pharmacies, Purchase department of different accounts and support staff of the account to name a few. Implement effective sales strategies for his territory under the guidance of the DSM and with the help of Brand promotion, Strategies Implementation and Execution effectively to achieve his territorys budget. Identify the key accounts for negotiation and closing the business agreements. Provide timely feedback and suggestions to the DSM on his/her territorys clients needs. Ensure implementation of CRM and KOL engagement plans in his/her territory in conjunction with marketing and medical affairs team. Identify new potential customers and new market opportunities from his territory. Accountable for his/her territory’s Collections/Management of accounts receivables. Prepare & participate in periodic sales review of his territory by the DSM and suggest way-forward to surpass his/her territory revenue targets.

Production Officer/ Sr. Officer/Executive (Injectable Only)

Navsari

1 - 5 years

INR 2.0 - 5.0 Lacs P.A.

Work from Office

Full Time

Role & responsibilities 1. Follow the instruction & procedure given in Entry- Exit SOP (Standard Operating Procedure) of Grade C, decartoning area and Grade B’ area. 2. Responsible a procedure for proper functioning or behaviour in aseptic area. 3. Follow the personnel hygiene practices in factory premises. 4. Follow the GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) as per given in SOP. 5. Responsible for monitoring of temperature, relative humidity and differential pressure. 6. Responsible for monitoring of differential pressure of laminar air flow units and pass boxes. 7. Responsible for handling of material movement in production area. 8. Responsible for maintain the document as per GDP and area as per cGMP. 9. Responsible for to maintain day to day records. 10. Responsible for training to new joining chemist, workers and operators for their respective job. 11. Carrying out the line clearance before starting the operation. 12. Responsible for planning of manufacturing as per availability of RM and PM. 13. Responsible for supervision of preparation and filtration of cleaning/ disinfectant solutions and fogging solutions. 14. Responsible for supervision of equipments/ machines and utility readyness before batch manufacturing. 15.Responsible for supervision of operation and cleaning of steam sterilizer, compounding vessel and holding vessel, vial washing machine, sterilization and depyrogenation tunnel, washing and drying and wrapping of garments and pass box and laminar air flow. 16. Responsible for supervision of handling of filters, filter integrity testing apparatus, silicon tubing, decartoning area and hose pipes and cleaning and wrapping of glassware, auxiliary items and machine parts. 17. Responsible for supervision of operation of pH meter and stirrer. 18. Responsible for supervision of aseptic process stimulation, post media fill cleaning and sanitization of machine and area as per procedure. 19. Responsible for destruction of media filled vials. 20. Responsible for supervision for general area cleaning and sanitization of grade ‘C’ and ‘D’ area and fogging activity of respective area. 21. Responsible for verification of load cell. 22. Responsible for verifying the handling of waste generated in production area. 23. Responsible for non viable particle count (online and offline) monitoring. 24. Recording the operation and cleaning details in batch manufacturing record and equipment uses log book. 25. Responsible for handling of equipment like homogenizer, rota evaporator, magnetic stirrer, ultrsonicator, pH meter and fogger. 26. Follow the procedure for dispensing room and responsible for RM and PPM dispensing and additional materials issuance. 27. Responsible for all data entry for batch manufacturing process in pharmacloud system. 28. Responsible for audit preparation and execution. 29.To undergo periodic medical checkup arranged by the company. 30.Performing the task assigned by the supervisor. 31. Reporting regarding unsafe act/ unsafe condition/ accident/ incident to supervisors. Preferred candidate profile Candidate Should have Exposure of Pharma Injectable Plant. Candidate Should well familiar with Pharma Guidelines. Candidate should have good Verbal and Written Communication Willing to Relocate in Navsari, Gujarat, Willing to Work in a Shift.

Microbiology - Officer/Sr. Officer /Executive

Navsari

0 - 5 years

INR 1.0 - 6.0 Lacs P.A.

Work from Office

Full Time

Role & responsibilities 1. Responsible for Daily sampling and analysis of in-process and water samples as per procedure. 2. Responsible For Preparation and pouring of media plate. 3. To perform BET (Bacterial Endotoxin Test) test and Microassay. 4. To perform Sterility Test, Bioburden and MLT (Microbial Limit Test) or water and product. 5. To Perform Growth Promotion / Inhibitory / Indicative Property Test Of Media. 6. To report results of analysis in raw data sheet issued. 7. Entry and maintain all micro related logbooks. 8. To Follow the QMS (Quality Management System) system (Out of Specification, Deviation, Incident) 9. To participates in validation activity. 10. Observation and review of media fill container. 11. To perform environmental monitoring in clean room as per standard operating procedure. 12. To run the autoclave cycles and unload the loads as per SOP (Standard operation procedure). 13. To monitor incubator condition daily and record, to take print out and verify. 14. To maintain the GLP (Good laboratory practices) and follow GDP (Good documentation practices) in the laboratory. 15. To run washing and drying machine. 16. To raise Out of Specification if noticed. 17. Responsible to perform analysis of Analytical method Validation, Analytical method Transfer, reconstitute Solution stability, additional analytical test required as per party quarry reply. 18. Responsible for preparation Analytical method validation protocol, raw data, report. 19. Responsible for review of Analytical method validation protocol, raw data, report. 20. Responsible for preparation excel sheet preparation of analytical method validation, method transfer, Reconstitute Solution Stability study. 21. Responsible for planning of method validation activity. Requirement of sample, standard, reference standard, column, instrument provide to the analyst. 22. Responsible for training providing to the analyst for analytical method validation and method transfer SOPs (Standard operating procedures). 23. Responsible to control and maintain records like protocols, raw data, and report of method validation, method transfer and reconstitute solution stability. Analysis records, usage log books and status labels during day to day Analysis of validation. 24. Any other Responsibility assigned by HOD (Head of Department). 25. To assist HOD (Head of Department) for the preparation of regulatory inspection. Preferred candidate profile Candidate Should be From Pharma Background Good Verbal and Written Communication Willing to Relocate in Navsari , Gujarat Willing to Work in a Shift

Sr. Officer/ Executive/ Sr. Executive - Human Resource (Navsari)

Navsari

3 - 8 years

INR 3.0 - 6.0 Lacs P.A.

Work from Office

Full Time

Role & responsibilities : Performance Management System Performance Appraisal KRA KPI Recruitment and Selection Talent Acquisition Preferred candidate profile candidate has excellent communication skill Should have experience in core HR Should Completed Post Graduation In HR field

Quality Assurance - Manager (Injectable Only)

Navsari

15 - 18 years

INR 15.0 - 17.0 Lacs P.A.

Work from Office

Full Time

Role & responsibilities Responsible for defining QA strategy, approach and execution in the field of document control, IPQA, qualification/validation, GLP, training activities etc. and responsible for leading and directing QA team To approve SMF, VMP, quality manual and validation protocol. To conduct internal audit / self-inspection to ensure compliance to GMP and another regulatory requirement. To arrange management review meeting and escalate the outcome of quarterly report to management. To handle the Market Complaints and to participate in Product Recall. To approve quality system documents likes Change controls proposals, Deviations, Incident reports, CAPA reports, OOS and OOT, NCR, Market Complaints, product recalls and Returned goods. Responsible for review and approval of new as well as revised related Specification, Standard Test Procedure and Analytical Work Record. Responsible to design validation/ qualification strategies Responsible for validation /qualification of processing equipments, cleaning equipments and testing equipments on time. Responsible for day-to-day validation planning and execution activity. Responsible to approve specifications, standard test procedures and analytical work records. To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports. Responsible for regulatory & customer audits preparation, execution and its compliance. To approve and authorize technical agreements from customer and outside party. Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department. Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing. To ensure the implementation of quality risk management procedures. Responsible to finalize training topics as per requirement and organize annual training plan with Training coordinator on cGMP and technical aspects. To ensure that processes needed for the Quality Management System are established, implemented and maintained. Responsible for investigation & review of non-conforming events including customer complaints and internal non-conforming events. Responsible for report, review, evaluation and tracking of change control, deviation, incident, market complaint, non-conformance report, product recall, corrective and preventive action. Responsible to ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of Quality Management System. Responsible to perform vendor audits and internal audits. To check audit trial and back-up verification documents. Participation in study raised through Quality Management System.

Officer / Sr. Officer / Executive EHS

Navsari

3 - 8 years

INR 2.5 - 5.0 Lacs P.A.

Work from Office

Full Time

Roles and Responsibilities Responsible for GPCB work, SOP Preparation, Periodic Revision of EHS SOP, Work Permit System, Documentation work etc. ETP and STP Knowledge. Plastic Waste (ERP) related Knowledge. Knowledge of CGWA. should knowledge of EC compliance uploading process on Parivesh Portal. Knowledge of MEE. Responsible for Regulatory Compliance Responsible for Statutory Audit, Safety Audit. Responsible for Risk Assessment, Incident Investigation, Hazard dentification. Responsible for Safety Training to new joiners. Responsible for Legal Compliance. Responsible for Environment Audit.

Quality Assurance - IPQA, QMS (Officer/Sr. Officer/ Executive) Navsari

Navsari

2 - 7 years

INR 2.5 - 6.0 Lacs P.A.

Work from Office

Full Time

Role & responsibilities IPQA:- Responsible for line clearance and in process checks of Production. Responsible for Sampling of in-process, Finished Product, control samples, stability samples, and Process Validation samples as per procedure. To ensure online rejection activities and environment monitoring in manufacturing and packaging areas. To conduct periodical log review. To review of batch documents (Batch Manufacturing, Batch Packaging records, and Quality Control analysis data of the batch). To ensure online documentation during manufacturing and packaging area. To prepare and review of Quality Assurance Standard Operating Procedures. To ensure Re-processing and Re-packing activity. Responsible to perform Acceptance Quality Limit and Pre Dispatch Inspection of finished product. Responsible for preparation of Annual Product Quality Review. Responsible to maintain the document as per current Good Manufacturing Practices. Responsible to initiate Change control\Deviation\Incident\Market complaint\non-conformance investigation. To assist the Head of Department for preparation of regulatory inspection. Any other responsibility assigned by Head of Department. Quality Management System:- 1. To coordinate with cross functional department for execution of training planners and maintain training record for same. 2. To master, issue and retrieve of SOPs/BMR/BPR/QC dockets and other documents in-line with the laid down procedure. 3. To maintain vendor related documents and conduct vendor audits. 4. To investigate and prepare Market Complaint investigation report. 5. To take follow up and communicate with customer/vendor regarding Complaint. 6. To handle Change control/Deviations/Incidents/NCR/CAPA. 7. Review of quality technical agreements.

Quality Assurance - Validation (Officer/Sr. Officer/Executive) Navsari

Navsari

2 - 7 years

INR 2.5 - 5.0 Lacs P.A.

Work from Office

Full Time

Roles and Responsibilities Responsible to design validation/ qualification strategies. Responsible for validation /qualification of processing equipment's, cleaning equipment's and testing equipment's on time. Responsible to review & approve of validation /qualification protocols and reports. Responsible for day to day validation planning and execution activity. Planning, Execution & Participation of aseptic process simulation activity. Responsible for process validations, hold time studies, thermal studies, transport validation, filter validation etc but not limited. Responsible to design, review, approve and implementation of departmental standard operating procedures. Responsible to review, approval and authorization of all standard operating procedure of the site. Responsible to approve specifications, standard test procedures and analytical work records. Responsible to approve master batch manufacturing records and master batch packing records. Responsible to integrate all the standard operating procedures and to design a quality system to prevent and correct quality related subjects. To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports. To handle the market complaints and to participate in product recall. Responsible to perform vendor audit & approve vendor for raw materials, packing materials, contract manufacturing facilities & contract testing laboratories. Responsible to finalize annual GxP / Technical training planner as per requirement and Its Plan, execution as planner. Responsible to conduct internal audit /self-inspection to ensure compliance to cGMP and other regulatory requirements. Responsible for regulatory & customer audits preparation, execution and its compliance. Responsible to review of annual product quality review, environment monitoring trends & water systems testing trends. Responsible to co -orientate with internal as well as external department personnel to maintain the CGMP environment Responsible to update & maintain online departmental documentation. To ensure supply of products and service are having acceptable standards. To approve and authorize technical agreements from customer and outside party. To approve & authorize protocol received from outside party. Responsible to approve and authorize destruction of rejected materials/batches. Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department. Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing. Responsible to inform top management for future requirement of departmental up-gradation necessary for the growth of organization and to meet regulatory requirement. To ensure the implementation of quality risk management procedures. To ensure that proper implementation of data integrity policies. Responsible to approve SMF, VMP, quality manual and project validation documents & release the batch after the compliance with the specifications in absence of Senior Manager QA. Desired Candidate Profile Candidate Should have experience in Injectable plant only Good Verbal & Written skill Proficient in Ms office/Excel & Word Perks and Benefits Medical Reimbursement Subsidized Accommodation for Bachelors Professional Development Paid time off Work/life Balance

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Gufic Group

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Gufic Group

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Pharmaceuticals

Goregaon (West)

1000+ Employees

11 Jobs

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