276 Jobs in Medak - Page 8

Job Overview This is to upkeep the manufacturing assets to ensure availability and reliability,ensuring the smooth operation and reliability of equipment and facilities for the API plant Key Stakeholders: Internal Cross - functional teams at Digwal site like Production, QA, QC, HR, TSD, SCM , EHS, Administration etc Key Stakeholders: External Statutory and Regulatory agencies, External Suppliers, Engineering Contractors, Service providers & Customers (on need basis) Reporting Structure Role reports to: General Manager Engineering Experience 15-20 Years experience preferably in API plants Engineering and Maintenance (E&M) function. The incumbent should have exposure to managing Breakdown, Preventive maintenance, troubleshooting related API manufacturing. Blocks, Clean Rooms, HVAC, Utilities, Boiler, Electricals, Instrumentation and managing CAPAs. Should have academics understanding, operational know-how of Utilities, Electricals, Instrumentation, HVAC to maximize performance and optimizing OPEX into these areas. Should understand the KPIs of E&M function, working in matrix reporting environment to manage Corporate initiatives and Compliances. Have a passion and past exposure to drive for high standard of Safety and Compliance standard into day-to-day work, meeting EHS & statutory compliances and realizing zero incident performance Competencies: Ability to manage a large team and guide them to achieve functional objectives Stakeholder management internal and external Structured approach to manage overall E&M work and quick learning attitude to adapt cultural changes. High analytical abilities to spot on actual reasons for gaps in asset performance, energy performance and other E&M performances. Good level of understanding on Process oriented approach to designing and managing the work. Inter-personnel skills to work in matrix reporting, managing stake holders, working with Piramal Corporate Engineering. Multitask master to work in highly dynamic CMO Business environment. Key Role & Responsibilities: Responsible for Maintenance of API Plant with exposure to Mechanical, Electrical, Utilities and Instrumentation areas . Responsible for the complete E & M function to act as HOD in absence of HOD. Exposure to Utilities and Electrical efficiencies and to contribute into Energy efficiencies and ESG program. Jobs assigned time to time by HOD (E&M). He has been trained to perform Qualified Auditor. Responsible for internal Audits on time action closures as per the date & Agenda Circulated by QA & EHS. Develop & prepare work procedures to minimize OHS risks and Adverse environment effect. Comply with SHE Guidelines, SHE Rules and Regulations. Implement emergency control plan. Maintain all relevant records under OHSAS & EMS Systems. Ensure compliance to Hazardous waste and chemical management. Managing to complete observed unsafe acts and conditions and take corrective & preventive actions as per plan. Responsible for on time completion of all the maintenance work as per the satisfaction of end user. Responsible for in time payment of maintenance work carried out by fabricators & Contractors. Responsible for quality of maintenance work carried out by fabricators and contractors as per the specifications in timely manner. Responsible for carrying out breakdown investigation for any incident / accident/ near miss / illness and report if his superiors in two working days Responsibilities BE - Mechanical

To ensure that all the computerized systems meeting the 21 CFR part11, EU ANNEX 11and GAMP5 guidelines requirements. Involvement during the computerized system validations and there by reviewing the validation documents. Coordinating with corporate QeC & IT teams to implement best practices with ITC Governance initiatives and corporate policies. Providing support in periodic assessments to ensure the compliance of defined IT related SOPs and procedures of computerized systems. Performing investigations related to computerized systems, there by identifying the root cause and making sure that adequate CAPA is in place. Responsible for review of IT supplier assessment and ensure that all the softwares are in compliance. Involving and providing support during customer and regulatory audits. Responsible for handling Data Integrity (DI) initiatives at site. Responsible to perform internal self & DI audits for IT related systems. To conduct trainings on computer system validation, 21 CFR part11, EU ANNEX 11 and GAMP5 guidelines for site teams. Responsible for review of SOPs related to IT systems. Responsible for review of change controls and deviations related to IT systems. Coordinates with all functional departments to do uninterrupted GMP and 21 CFR Part 11 implementations and report the concerns/status on day today basis to reporting manager. In my absence, responsible manager shall take care of my responsibilities. Any other works allotted by the Head Quality / QA / Designee on day to day basis. Qualifications B.Tech/M.Sc

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPIC. Responsible for allotting the work to the chemist within the raw material section. Responsible for performing the calibrations of all instruments in raw material section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the FP section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, deviations and CAPA implementations Responsible for review of SOPs , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COAs as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Qualifications B.Sc / B. Pharmacy / M.Sc / M. Pharmacy

Printing of GMP documents i.e. SOPs (ENSUR) other related documents. Handling of ENSUR system for SOP generation, issuance, and retrieval from concern departments. ATRs, STPs, Stability Protocols and other documents Photocopying, Stamping, Numbering, and Issuance and retrieval from concern departments. Hard Books & Losse Formats Issuance SOPs STPs obsolete documents destruction and filing of the master copy. ENSUR trouble shooting and to ensure the timely completion of SOP generation from the system. Supporting during Audits for fast retrieval of documents. Handling of reserve samples Review of Executed BMRs and ECRs. Issue of Product labels for dispatch related activity. Observe unsafe acts and conditions and take corrective & preventive actions immediately. Report any incident / accident / near miss / illness to the superiors. Identify unsafe conditions and unsafe acts and report to superiors. Issuance of archival documents. Issuance of Executed BMRs, BPRs. And any other job as may be assigned to you from time to time. Also responsible for the work of his senior in the absence of senior. Qualifications B.Sc/B. Pharmacy/M.Sc

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOPs , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COAs as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Qualifications Bachelor's degree

Key Roles & Responsibilities 1. Participate and adhere in all EHS continual improvement & line responsibilities (Eg. Emergency mock drill participation, training, permit to work, etc.) And responsibilities mentioned in the site EHS procedures. 2. Follow all the site safety requirements and exhibit positive behavior in the safety culture transformation. 3. Follow the all permit to work procedure in shop-floor activities. 4. Follow the required Personnel Protective equipment (PPE) usages during performing the shop-floor operations. 5. Identify the unsafe conditions / unsafe acts and report to Manager/EHS team and report any safety-related incidents, accidents, learning incidents or illnesses to the OHC / Superiors / Manager immediately. 6. Follow the previous shifts information / Managers instructions and complete the assigned tasks, on time. 7. Ensure that executed BMRs, BPRs, ECRs review timely and submit to QA, as soon as possible, based on the requirement. 8. Review & update the shop-floor documents contemporaneously i.e. BMRs, BPRs, ECRs, Logbooks, Protocols, Reports, Checklists, etc. 9. Update the shift logbook as per the process status as well as any priorities or instructions, and hand it to the reliever during the shift change. 10. Impart the trainings on SOPs, revised documents & qualification protocols/ reports to shop-floor personnel. 11. Strictly follow the SOPs on shop-floor. 12. Ensure all the raw material as per RM indent and keep ready for the batches. 13. Raise the work order for maintenance works & coordinate with E&M team for the completing tasks the in time. 14. Co-ordinate with engineering department for performing the scheduled equipment Preventive Maintenance (PM) and instrument calibrations. 15. Ensure batch execution in line with the production schedule. 16. Ensure the cleanliness and good housekeeping in respective areas. 17. Manpower planning to be done based on production priorities, in shifts. 18. Participate in the trainings as per the schedule. 19. In the absence of the Superior, responsible for his work. Qualifications BE/B. Tech chemical.

To carryout filling and packing activities as per BFR, BPR & SOPs. To follow & maintain current GMP standards in production area/activities. To follow day-to-day production schedule and ensure to complete production activities (filling & packing) as per schedule. To take & follow operating instructions for the shift activities from superior/Manger If any abnormality found in production area / activities, authorized to stop activity immediately & highlight to production Manager. To maintain manufacturing records online & should comply data integrity practices. Indenting, issuance & submission of BFR/BPR. Verification of Raw material & Packing material during receipt. SAP posting as per BFR & BPR. Sample request/submission to QC after filling activity. Transfer finished goods through Finished Goods Transfer Note. Carryout cleaning of filters & storage tanks as per schedule. Ensure & Maintain cleanliness in production area as per SOP. Ensure cleaning of AHU filters as per schedule. To Check and ensure minimum stock of consumables, Log books & status labels. Ensuring preventive maintenance of all equipment as per schedule. Maintain temperature & RH within SOP limits in production area. Co-ordinate with service departments (QA, QC, stores, E & M and SCM) for various production related activities. To follow safety instructions/procedures & ensure use of safety outfit while on works. Responsible to carry out the work of his senior in the absence of senior or authorization from senior. Qualifications B. Pharmacy or equivelent

Responsibilities of candidates include *Treating patients like dressing,grooming,toileting *Maintaining patient Paper work *Observe and Monitor Patient Health *Need to stay at patient house

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOP s , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COA s as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA / Production / PPIC / Warehouse / TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Bachelors degree

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPIC. Responsible for allotting the work to the chemist within the raw material section. Responsible for performing the calibrations of all instruments in raw material section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the FP section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, deviations and CAPA implementations Responsible for review of SOP s , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COA s as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA / Production / PPIC / Warehouse / TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. B.Sc / B. Pharmacy / M.Sc / M. Pharmacy

To carryout filling and packing activities as per BFR, BPR & SOPs. To follow & maintain current GMP standards in production area/activities. To follow day-to-day production schedule and ensure to complete production activities (filling & packing) as per schedule. To take & follow operating instructions for the shift activities from superior/Manger If any abnormality found in production area / activities, authorized to stop activity immediately & highlight to production Manager. To maintain manufacturing records online & should comply data integrity practices. Indenting, issuance & submission of BFR/BPR. Verification of Raw material & Packing material during receipt. SAP posting as per BFR & BPR. Sample request/submission to QC after filling activity. Transfer finished goods through Finished Goods Transfer Note . Carryout cleaning of filters & storage tanks as per schedule. Ensure & Maintain cleanliness in production area as per SOP. Ensure cleaning of AHU filters as per schedule. To Check and ensure minimum stock of consumables, Log books & status labels. Ensuring preventive maintenance of all equipment as per schedule. Maintain temperature & RH within SOP limits in production area. Co-ordinate with service departments (QA, QC, stores, E & M and SCM) for various production related activities. To follow safety instructions/procedures & ensure use of safety outfit while on works. Responsible to carry out the work of his senior in the absence of senior or authorization from senior. B. Pharmacy or equivelent

Shall be responsible for Process Safety Management which includes implementation of 14 elements of OSHA process Safety management. Review of MOC, Hazard Studies, PSSR, BMR Reviews, Management and preservation of Process Safety documents. Tracking Process Safety CAPA using digital platform. Graduation (B.Tech / BE)

Process mapping of new products Mapping of new products in existing blocks Monitoring the progress of new RFP s Basic and detail engineering for new production blocks Coordinating with consultant for basic and detail engineering for new production blocks. Coordinating with different functions such as Production, SCM, Projects, PM, RD etc. for smooth implementation of new products. Process Safety evaluation of new products. Monitoring of new products during the manufacturing and note observations for further improvements. Preparation of batch plan for new products and monitor to closely to implement within time line. Work towards solvent recovery/recycle and re-use for the new products. B. Tech chemical engg

Printing of GMP documents i. e. SOPs (ENSUR) other related documents. Handling of ENSUR system for SOP generation, issuance, and retrieval from concern departments. ATRs, STPs, Stability Protocols and other documents Photocopying, Stamping, Numbering, and Issuance and retrieval from concern departments. Hard Books Losse Formats Issuance SOPs STPs obsolete documents destruction and filing of the master copy. ENSUR trouble shooting and to ensure the timely completion of SOP generation from the system. Supporting during Audits for fast retrieval of documents. Handling of reserve samples Review of Executed BMRs and ECRs. Issue of Product labels for dispatch related activity. Observe unsafe acts and conditions and take corrective preventive actions immediately. Report any incident / accident / near miss / illness to the superiors. Identify unsafe conditions and unsafe acts and report to superiors. Issuance of archival documents. Issuance of Executed BMRs, BPRs. And any other job as may be assigned to you from time to time. Also responsible for the work of his senior in the absence of senior. B. Sc/B. Pharmacy/M. Sc

Knowledge of QMS all elements and hands on experience in investigations, report writing and audit handling. Post Graduate 12-15 years minimum experience in QA function. Knowledge of QMS all elements and hands on experience in investigations, report writing and audit handling.

Job Description Key Roles & Responsibilities Participate and adhere in all EHS continual improvement & line responsibilities (Eg. Emergency mock drill participation, training, permit to work, etc.) And responsibilities mentioned in the site EHS procedures. Follow all the site safety requirements and exhibit positive behavior in the safety culture transformation. Follow the all permit to work procedure in shop-floor activities. Follow the required Personnel Protective equipment (PPE) usages during performing the shop-floor operations. Identify the unsafe conditions / unsafe acts and report to Manager/EHS team and report any safety-related incidents, accidents, learning incidents or illnesses to the OHC / Superiors / Manager immediately. Follow the previous shift’s information / Manager’s instructions and complete the assigned tasks, on time. Ensure that executed BMRs, BPRs, ECRs review timely and submit to QA, as soon as possible, based on the requirement. Review & update the shop-floor documents contemporaneously i.e. BMRs, BPRs, ECRs, Logbooks, Protocols, Reports, Checklists, etc. Update the shift logbook as per the process status as well as any priorities or instructions, and hand it to the reliever during the shift change. Impart the trainings on SOPs, revised documents & qualification protocols/ reports to shop-floor personnel. Strictly follow the SOPs on shop-floor. Ensure all the raw material as per RM indent and keep ready for the batches. Raise the work order for maintenance works & coordinate with E&M team for the completing tasks the in time. Co-ordinate with engineering department for performing the scheduled equipment Preventive Maintenance (PM) and instrument calibrations. Ensure batch execution in line with the production schedule. Ensure the cleanliness and good housekeeping in respective areas. Manpower planning to be done based on production priorities, in shifts. Participate in the trainings as per the schedule. In the absence of the Superior, responsible for his work. Qualifications BE/B. Tech chemical. About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide. Show more Show less

Job Description To carryout filling and packing activities as per BFR, BPR & SOPs. To follow & maintain current GMP standards in production area/activities. To follow day-to-day production schedule and ensure to complete production activities (filling & packing) as per schedule. To take & follow operating instructions for the shift activities from superior/Manger If any abnormality found in production area / activities, authorized to stop activity immediately & highlight to production Manager. To maintain manufacturing records online & should comply data integrity practices. Indenting, issuance & submission of BFR/BPR. Verification of Raw material & Packing material during receipt. SAP posting as per BFR & BPR. Sample request/submission to QC after filling activity. Transfer finished goods through “Finished Goods Transfer Note”. Carryout cleaning of filters & storage tanks as per schedule. Ensure & Maintain cleanliness in production area as per SOP. Ensure cleaning of AHU filters as per schedule. To Check and ensure minimum stock of consumables, Log books & status labels. Ensuring preventive maintenance of all equipment as per schedule. Maintain temperature & RH within SOP limits in production area. Co-ordinate with service departments (QA, QC, stores, E & M and SCM) for various production related activities. To follow safety instructions/procedures & ensure use of safety outfit while on works. Responsible to carry out the work of his senior in the absence of senior or authorization from senior. Qualifications B. Pharmacy or equivelent About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders. PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators. Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space. Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment. Show more Show less

Key Roles Responsibilities 1. Participate and adhere in all EHS continual improvement line responsibilities (Eg. Emergency mock drill participation, training, permit to work, etc. ) And responsibilities mentioned in the site EHS procedures. 2. Follow all the site safety requirements and exhibit positive behavior in the safety culture transformation. 3. Follow the all permit to work procedure in shop-floor activities. 4. Follow the required Personnel Protective equipment (PPE) usages during performing the shop-floor operations. 5. Identify the unsafe conditions / unsafe acts and report to Manager/EHS team and report any safety-related incidents, accidents, learning incidents or illnesses to the OHC / Superiors / Manager immediately. 6. Follow the previous shift s information / Manager s instructions and complete the assigned tasks, on time. 7. Ensure that executed BMRs, BPRs, ECRs review timely and submit to QA, as soon as possible, based on the requirement. 8. Review update the shop-floor documents contemporaneously i. e. BMRs, BPRs, ECRs, Logbooks, Protocols, Reports, Checklists, etc. 9. Update the shift logbook as per the process status as well as any priorities or instructions, and hand it to the reliever during the shift change. 10. Impart the trainings on SOPs, revised documents qualification protocols/ reports to shop-floor personnel. 11. Strictly follow the SOPs on shop-floor. 12. Ensure all the raw material as per RM indent and keep ready for the batches. 13. Raise the work order for maintenance works coordinate with EM team for the completing tasks the in time. 14. Co-ordinate with engineering department for performing the scheduled equipment Preventive Maintenance (PM) and instrument calibrations. 15. Ensure batch execution in line with the production schedule. 16. Ensure the cleanliness and good housekeeping in respective areas. 17. Manpower planning to be done based on production priorities, in shifts. 18. Participate in the trainings as per the schedule. 19. In the absence of the Superior, responsible for his work. BE/B. Tech chemical.

To ensure that all the computerized systems meeting the 21 CFR part11, EU ANNEX 11and GAMP5 guidelines requirements. Involvement during the computerized system validations and there by reviewing the validation documents. Coordinating with corporate QeC IT teams to implement best practices with ITC Governance initiatives and corporate policies. Providing support in periodic assessments to ensure the compliance of defined IT related SOP s and procedures of computerized systems. Performing investigations related to computerized systems, there by identifying the root cause and making sure that adequate CAPA is in place. Responsible for review of IT supplier assessment and ensure that all the software s are in compliance. Involving and providing support during customer and regulatory audits. Responsible for handling Data Integrity (DI) initiatives at site. Responsible to perform internal self DI audits for IT related systems. To conduct trainings on computer system validation, 21 CFR part11, EU ANNEX 11 and GAMP5 guidelines for site teams. Responsible for review of SOP s related to IT systems. Responsible for review of change controls and deviations related to IT systems. Coordinates with all functional departments to do uninterrupted GMP and 21 CFR Part 11 implementations and report the concerns/status on day today basis to reporting manager. In my absence, responsible manager shall take care of my responsibilities. Any other works allotted by the Head - Quality / QA / Designee on day to day basis. B. Tech/M. Sc

More than 5 year experience in QMS like handing of change control, deviation, OOS and Audit properness and Audit facing knowledge of electronic system like Track wise, SAP. . . . MSc Chemistry/ BTech Chemical

Key Roles Responsibilities 1. Participate and adhere in all EHS continual improvement line responsibilities (Eg. Emergency mock drill participation, training, permit to work, etc. ) And responsibilities mentioned in the site EHS procedures. 2. Follow all the site safety requirements and exhibit positive behavior in the safety culture transformation. 3. Follow the all permit to work procedure in shop-floor activities. 4. Follow the required Personnel Protective equipment (PPE) usages during performing the shop-floor operations. 5. Identify the unsafe conditions / unsafe acts and report to Manager/EHS team and report any safety-related incidents, accidents, learning incidents or illnesses to the OHC / Superiors / Manager immediately. 6. Follow the previous shift s information / Manager s instructions and complete the assigned tasks, on time. 7. Ensure that executed BMRs, BPRs, ECRs review timely and submit to QA, as soon as possible, based on the requirement. 8. Review update the shop-floor documents contemporaneously i. e. BMRs, BPRs, ECRs, Logbooks, Protocols, Reports, Checklists, etc. 9. Update the shift logbook as per the process status as well as any priorities or instructions, and hand it to the reliever during the shift change. 10. Impart the trainings on SOPs, revised documents qualification protocols/ reports to shop-floor personnel. 11. Strictly follow the SOPs on shop-floor. 12. Ensure all the raw material as per RM indent and keep ready for the batches. 13. Raise the work order for maintenance works coordinate with EM team for the completing tasks the in time. 14. Co-ordinate with engineering department for performing the scheduled equipment Preventive Maintenance (PM) and instrument calibrations. 15. Ensure batch execution in line with the production schedule. 16. Ensure the cleanliness and good housekeeping in respective areas. 17. Manpower planning to be done based on production priorities, in shifts. 18. Participate in the trainings as per the schedule. 19. In the absence of the Superior, responsible for his work. BE/B. Tech chemical.

Business: PPL Digwal Department: PTS Location: Digwal Job Overview: To perform ARD actives as per GMP Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - ARD (Service) Key Stakeholders: Internal: QC, QA, SCM Safety External: NA Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol report, method validation protocol report, method development report, specification, standard test procedure etc. 9. Should aware about GLP practices and 21 CFR part-11. 10. Keep the work area clean and the laboratory under controlled temperature. 11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs. 12. Understand the safety and environmental aspect. 13. Maintain the reagents and standardize the volumetric solutions as per schedule. 14. Maintain the laboratory journals and instrument log books online. 15. Ensure compliance to Hazardous waste and chemical management. Qualification : M. Sc (Analytical Chemistry), (Chemistry) (Organic Chemistry)

Business: PPL Digwal Department: PTS Location: Digwal Job Overview: To perform Production actives as per GMP Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - RD (Service) Key Stakeholders: Internal: QC, QA, SCM Safety External: NA Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles Responsibilities 1. Design the scheme of experiments. 2. Plant trouble shooting, investigation and root cause analysis. 3. IUT support for vendor qualification and plant batches. 4. Carry out experiments during the feasibility and optimization stage. 5. Visualize the development needs of the product. 6. Understand the safety and environmental aspect. 7. Solve the problems and queries related to the development of the product and discuss them with the Group Leader / HOD. 8. Familiarize with the problems faced during scale-up and identifying all critical process parameters for a seamless scale-up 9. Knowledge on IUT, VQ, LFR/PDR reports documentation. 10. Understand the scalability of the chosen process, in coordination with TSD and Production. 11. Amicable relationship with PRD and ARD and work planning accordingly 12. Keep the Group Leader well informed about the experiments and their results by maintaining the lab journal/ documents well. 13. Technology Transfer for new project to Production plant. 14. Document project progress regularly with all relevant information. 15. Document all the relevant data in systematic manner and regularly discuss with group leader for way forward. 16. Required literature survey knowledge on project progress timely and discuss with group leader. 17. Mentor and guide the junior chemists in the lab on process development. Responsible for his/her training needs and appraisal along with the Group leader. 18. Keep the work area clean and the laboratory auditable all the time. 19. Responsible for department related administrative activities identified by the group leader/HOD from time to time. 20. Flexible for working on project requirement. 21. Voluntarily involve in additional responsibilities. , Safety related, ESI, and corporate social responsible programs based on requirement 22. Ready, responsible and accountable for changes as per internal and customer requirements for successful execution of project on time as and when required. Qualification : M. Sc (Chemistry) (Organic Chemistry)

Job Description Process mapping of new products Mapping of new products in existing blocks Monitoring the progress of new RFP’s Basic and detail engineering for new production blocks Coordinating with consultant for basic and detail engineering for new production blocks. Coordinating with different functions such as Production, SCM, Projects, PM, R&D etc. for smooth implementation of new products. Process Safety evaluation of new products. Monitoring of new products during the manufacturing and note observations for further improvements. Preparation of batch plan for new products and monitor to closely to implement within time line. Work towards solvent recovery/recycle and re-use for the new products. Qualifications B.Tech chemical engg About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide. Show more Show less

Job Description Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOP’s , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COA’s as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Qualifications Bachelor's degree About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide. Show more Show less