243 Batch Manufacturing Jobs - Page 6

JOB DESCRIPTION (Sr. Officer) Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches. Maintaining the area and equipment in orderly manner as per cGMP requirements in a good state of repair and sanitized condition. To perform online documentation with respect to departmental procedures as per good documentation. To impart training of operation and cleaning related SOP to all subordinates and operators. Co-ordination for IQ / OQ for any new equipments / system. To perform PQ for any new equipments / system. To follow all concern departmental SOPs for day to day operation and cleaning. To handle and manage material movement as per defined procedure and approved Batch Manufacturing Record / Batch Packing Record. Review, execution and implementation of Batch Manufacturing Records, Batch Packaging Records, Process Study Protocols, Process Study Reports and all relevant Documents. To follow all safety rules and departmental general instructions. To perform work other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.

Job Description Batch Manufacturing and Filling activity. Batch manufacturing experience of Solution, Emulsion, suspension and gel eye drop products. Preparation and review of Deviation investigation, Risk Assessment, Impact Assessment, Equivalency reports, URS and various other production related documents and monthly intervention reports. Responsible for audit preparation (Internal and regulatory) and compliance. Reconciliation of product at various stages of batch manufacturing and filling. Preparation and reviewing of SOP and compliance after implementation. QAMS related activity. Approved GMP trainer for provide training to team members. Preparation of Media fill BMR. Planning for production activities by coordinating with PPIC, PDL, Engineering, validation and QA. Work Experience 8 to 10 Years Education Graduation in Pharmacy Competencies Developing Talent Innovation & Creativity Result Orientation Strategic Agility Process Excellence Customer Centricity Collaboration Stakeholder Management

Handle the shift activity as per given planning. • Casual manpower handling, distribution, and proper utilization. • Work experience in manual plant. • Handling and good exposure in operation such as distillation, pump, Vacuum Ejector, ANF, Scrubber, SS316 and MSGL reactor. • Handling and good exposure of various solvent and chemical process. • Maintain good housekeeping. • Knowledge about SOP, batch process record. • Knowledge about MSDS. • Monitoring critical process parameter. • Knowledge on Safety, Health and Environment is must.

To review validation master plan of the plant and comply with the validation requirements of various regulatory authorities and customers. To review the process validation/ cleaning validation qualification protocols. To review SOPs, batch manufacturing and packing records, specifications, and test methods of the products. To monitor, control and review deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution. To ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guidelines as per Food safety Quality management system. To ensure that all critical equipment and utilities that are used to manufacture the product are under qualified status, calibrated and are under routine preventive maintenance program. To ensure proper investigation of market / customer / regulatory complaint by root cause analysis, corrective actions and ensure effective implementation of CAPA initiatives, close the complaints, send responses to the complainants, and verify effectiveness of CAPA periodically. To evaluate batch records, COAs and release finished products for sale. To ensure that, all the operations are carried out are as per GMP and laid down procedures, that each production batch complies with the provisions of Food safety standards (FSS) act and other legal, customer and regulatory requirements. To ensure compliance to the regulatory, customer, legal requirements and face audits and comply non-conformities observed during the audits. To ensure compliance to the current ISO 9001, DC Act, FSS Act 2006, FSSC 22000 (including HACCP), FAMI-QS, WHO-GMP and other customer and regulatory requirements. To carry out self inspections and ensure compliance to the audit observations of manufacturing, testing, warehousing facility. To ensure completion of APRs of products and take appropriate actions in case of deviations. Recommendation to recall approving authority on product recall, review, and disposition of recalled and returned goods. Handling of online and in process rejections and take appropriate actions to avoid the recurrences and disposition. To co-ordinate with CQA for up gradation in the SAP systems as per any changes or new product at Mahad site. To monitor stability of products, control sample storage and compilation of analytical reports and take appropriate action in case of failures. To identify and provide resources with co-ordination with other departments to carry out quality functions effectively. To liaison with regulatory authority for new product permissions, licenses and renewals, certificates, and approvals. Ensuring implementation and execution requirements of food regulations for export market (US)-21 CFR Part 110 111. Ensuring avoidance of breach of data integrity at all the levels. Ensuring implementation of effective sanitation activities at all the levels. Imparting required training to shop floor personnel. Adherence to the requirements of EHS norms. To raise the PR for procurement of miscellaneous items, external trainings, certification fees and capex related items. To sign the Excess Material Requisition, LRA notes, BMR return notes and other QMS documents in absence of Head- QA. To perform MSC2N transactions in SAP. Review of Change Control, Deviation, CAPA in trackwise. Implementation and execution of various initiatives as are suggested by corporate functions (SEEDS, Learning university, Quality mindset). SOP, BMR/BPR, layouts, STP review and approval in ENSUR system. To conduct vendor audits for RM/PM. To lead and guide the IPQA team for shopfloor activities. To set, review and evaluate KRA of reportees. To share the RR nominations of team members on quarterly basis. To identify and implement the OE projects. Patient/ Customer centricity. Qualifications B. Pharm/ M. Pharm

Strictly following cGMP, Safety and Environmental Practices. Filling of Batch Manufacturing record and equipment cleaning record. Following Good Manufacturing practices during operation. Ensuring Good Housekeeping in the respective plant area and its equipment. Usage of Proper personnel protective equipment as per requirement. Planning and ensuring RM availability for daily production as per production plan. Maintaining the documents like Issue and dispensing register. Carrying out the process as per BMR without any deviation. Ensuring the adherence to data Integrity in online documentation. Handling of Hazardous operation in safe manner. Effective utilization of resources like Utility, Men and Machine Qualifications Master's degree in relevant field. e.g., Chemical / Chemistry Ability to work collaboratively in a team-oriented environment. Strong communication skills, both verbal and written.

Preparation of CTD(Common Technical Documents) and ACTD(Asian Common Technical Documents) Dossiers for CIS (Commonwealth Independent States) and ROW (Rest Of World) Reviewing factory documents like Specifications, MOA (Mode Of Action), COA (Certificate Of Analysis), BMR (Batch Manufacturing Records), PVP (Polyvinylpyrrolidone), PVR (Pharmaco Vigilance Regulation), MFR (Master Formula Records), Stability Data etc.Reviewing DMF (Drug Master File) Reviewing Artworks and Labels. Co-ordinating with Factory for Documents. Preparation of Normative Document of Registered productsin CIS markets.Preparation of Excel sheet of Regulatory status. Response to Queries. Filing of Documents / Dossier. Preparation of DMF. Co-ordinating with respective person for Tender Documents. Filing of NDA (New Drug Application) & MAA (Marketing Authorisation Application). Other Regulatory / Compliances related responsibilities. Liaisoning with National & International Authorities for Regulatory related work. Candidate Profile: Presently working in similiar capacity i.e. as Export Executive/Manager with any leading Pharma Company. Candidate must be a Graduate/D.Pharm/B.Pharm or MBA preferably in Regulatory Affairs. 2 - 5+ years Andheri (E),Mumbai Local Resident of Mumbai preferred Male / Female Candidate Only Only those candidates who have worked in Pharma Industry in this profile.

Role & responsibilities : Supervise sterile manufacturing processes such as compounding, filtration, filling, and sealing of injectable products. Ensure compliance with cGMP, FDA, and other regulatory requirements in all production activities. Monitor and control environmental conditions in aseptic areas, ensuring cleanroom discipline is maintained. Coordinate with quality control, quality assurance, and engineering departments for production-related activities. Review and maintain batch manufacturing records (BMR), logbooks, and other relevant documentation. Perform in-process checks and ensure timely reporting of deviations and non-conformances. Assist in validation activities including media fill, equipment qualification, and process validation. Train and guide production staff on aseptic techniques, gowning procedures, and SOP adherence. Ensure timely availability of materials, equipment, and manpower for smooth production operations. Participate in internal and external audits and support compliance initiatives. Preferred candidate profile Education: B.Pharmacy/ M.Sc. Experience: 1-7 years in injectable (sterile) production in a pharmaceutical company. Knowledge of aseptic processing and cleanroom protocols. Familiarity with equipment like autoclaves, vial washers, filling lines, lyophilizers, and isolators. Understanding of documentation and regulatory requirements (e.g., USFDA, EU GMP, WHO GMP).

Candidates who has experience to work on multiple products and can handle batch production of maximum product. Only from Auto component Industry.

Role & responsibilities Achieve production as per plan Comply with documentation and reporting standards Improve and sustain GHK (5S) Achieve 'right first time' quality as per specifications Adhere to Co | Bu | Fu | department policies and SOPs (as applicable) Monitor usage of RM and utilities as per budgeted norms Conduct training programs for safety and productivity Coordinate with engineering for preventive maintenance Support initiatives to control fixed cost and continue improvement of process and safety Ensure optimum use of ERP system Preferred candidate profile Candidate have min 2 years of experience working in chemical manufacturing industry Interested candidates can direct share CV to diksheeta_patel@atul.co.in

company name=Apptad Technologies Pvt Ltd., industry=Employment Firms/Recruitment Services Firms, experience=4 to 7 , jd=Job Title:- EBMR AnalystJob Location:- HyderabadJob Type:- Full-Time/06 months - 1 year ContractualExp:- Min 4 to 7 MaxClient:- Vanguard LogisticsNo. of positions:- 2DurationImmediate:-Key aspects of an eBMR/MFG domain experts expertise include-Understanding of batch manufacturing processes-Knowledge of eBMR systems and their functionalities-Ability to identify and resolve issues-Collaboration and communication skills-Improve data accuracy and traceability-Enhance process efficiency-Designing and implementing eBMR systems-Training personnel on using the eBMR system-Developing and maintaining eBMR documentation, Title=EBMR Analyst, ref=6566491

Efficiencies to work long working hours (like as 10 to 11 Hrs.) Excellent knowledge of computer reservation process and MS Office. Shall be responsible for booking of Hotels/Flights/ Transportation as per the schedule shared To maintain the CRS on daily basis

Role & responsibilities Preparation and review of standard operating procedure. Monitoring of trend in the process and in the quality control. Preparation of Annual product quality review (APQR). Preparation of validation protocol & report. Reviewing of equipment qualification. To support the customer / regulatory audits. Follow up of CAPA. Handling of customer complaints. To support the preparation of new drugs endorsement / manufacturing license documents. Reviewing of stability data and monitoring of trend. Upkeep of documentation. Issue and control of documents. Issue batch production record. Issue and Retrieval of cleaning records. Review of batch production and equipment cleaning records. Documentation systems issue and control of documents. Upkeep of documentation. Issue of certificates photocopies to the user departments, with draw of obsolete copies and issue of uncontrolled copies whenever required. Checking the certificate of analysis prepared by quality control.

To perform Machine and area clearance during dispensing, manufacturing and packaging operation. To perform sampling of blend, finished product, reserve sample, stability sample, hold time samples and other in-process samples and to manage sampling aids. To carry out in-process checks, AQL and ANSI Sampling as per respective documents viz. protocol,BMR, BPR, SOPs and other GxP documents. To ensure GMP practices at manufacturing shop floor. To verify raw material dispensing activity. To approve batch coding details during packaging operation. Review of executed batch records and release for next processing stage. Preparation and review of CPV data trend. To perform impact assessment of breakdown memo. To initiate change control, unplanned and planned deviation where ever required. To review area, equipment and cleaning log and to ensure proper labelling. To review environmental monitoring record, calibration records and executed Batch Manufacturing and packaging Records and respective electronic records. To perform calibration of IPQA instruments. To ensure appropriate labelling during manufacturing and packaging. Storage, handling and dispensing of printed packing materials. To review and approve packaging artworks, proofs and shade cards. To archive executed documents like BMR, BPR, Hold time Protocol etc. To review and approve the Quality Notification (Viz Change control and Deviation) during Batch Manufacturing/packaging. To monitor and record the environmental condition of label control room. To prepare and revise functional SOPs, wherever required. Activities other than defined in the Job Responsibility are to be done, as per the requirement of HOD, by following HODS instructions and guidance.

Towork asper cGMP Norms. To carry out the processes of different products To make entry in BMR. To follow written SOP To follow instructions given by the Production Executive To ensure batch processing. To report any deviation occurred ONLY FRESHERS

*For Production (Parenteral/Injectable exposure only) : > Process Incharge/Sr. Process Incharge (Officer/Sr. Officer/Executive) : - To ensure the cleanliness, environmental norms and other process of various area like Dispensing, Mixing, Filling and Terminal Sterilizer. -To complete CIP, SIP and batch manufacturing process timely. -To ensure the batch manufacturing process is done as per Batch Manufacturing record. -To co-ordinate with other departments like QA, QC, Stores, Engineering, etc. as and when required. *For Packing (Parenteral/Injectable exposure only) : >Process Incharge/Sr. Process Incharge (Officer/Sr. Officer/Executive): - To make sure that issued material is as per requirement and the material quality is as per specification. -To check the availability of packing material with proper labels and status. -To ensure that the packing activity does not start without line clearance. -To check, verify and destroy the rejection generated during packing and ensure recording of all such material. -To update the Batch Packing Record online. -To check the packing online at frequent intervals as defined in the Standard Operating Procedure. -To train personnel for the critical operations like visual inspection and labeling. *For Stores (Pharmaceutical exposure only) : >Process Incharge (Officer/Sr. Officer): -Manage inventory levels by receiving, storing, and issuing materials according to GRN (Goods Received Note) and challans. -Ensure accurate recording of stock movements using FIFO (First-In-First-Out) method. -Maintain store cleanliness and organization to prevent damage or loss of goods. -Monitor inventory turnover ratios to optimize storage capacity utilization. -Perform regular physical counts to verify accuracy of recorded stock levels. Candidate Profile: Ready to work in rotational shifts. Excellent understanding about working area. Initiator and Learner. Decision making ability. Team player and if required, can provide training to other team members. Good communication. -The above positions are for shift (rotational) operations for the plant location (Vasana-Chacharwadi) and only for experienced candidates. -Fresher candidates can share their profile on hrm.opmf-amd@otsukapharma.in Note: Otsuka Pharmaceutical India Pvt Ltd does not hire any such consultants/agents who promise interviews/jobs for monetary consideration/registration fees. Beware of such fraudulent calls.

QA & R Manager is responsible for functions under QA from R.M. Inspection to Customer complaints systems compliance, audits leading all the QA operations in the company initiating & implementing continuous improvements to enhance product reliability Required Candidate profile Production Manager is responsible for heading the manufacturing operations. Monitor production output adjust workflow to meet customer demands & deliveries. Utilization manpower, material, machines

*Experience in production operations in Intermediate 1 API industry, Equipment & Utility Operations, Filing BMR I BPR, Distillation Process, having exposure of handling CF, Multi-Milling, AGNFD, FBD equipment. Required Candidate profile * Experience of working in API industry I Bulk Drug, having exposure of handling and preparation of Production cGMP documentation, Change Control, Deviation, 005 Investigation and CAPA etc.

Responsible for schedule & coordination, handling of internal audits and its documents. Management of vendor qualification documents, responsible for Vendor qualification of raw material, packaging material and critical service providers for testing, calibration, validation, transporters etc. Review, approval, tracking and ensure the quality agreements for all the critical material vendors, service providers, etc and with the customers as applicable. Batch release & dispatch: Review and or approve, release of executed batch records (Batch manufacturing, filling and packing records), analytical data by review and assess the related QMS documents such as change controls, deviation, complaints, incident & OOT etc. If any and the product related stability data. Responsibilities Qualifications BSC/MSC/ B.Pharmacy / M.Pharmacy ( 10 Years Experience )

Nutrizo Advancis Healthcare Private Limited is looking for IPQA-Chemist to join our dynamic team and embark on a rewarding career journey Conduct in-process quality checks during manufacturing Ensure compliance with GMP and SOP standards Document results and report deviations Coordinate with QA and production teams

Role & responsibilities Ensure the compliance of cGMP & EHS. Follow the cGMP requirement with appropriate housekeeping and documentation in manufacturing area. Co-ordination with other department for safe, successful and timely batch execution. Achieving plant production target w.r.t quality and yield. Active involvement in facing quality audits by vendor audit & regulatory audits. Lead from front to ensure safe behaviour / GMP culture on the shop floor. Comply with online documentation with complete data integrity. Undergo safety, quality and operational training & comply with requirement. Maintain housekeeping standard to ensure a clean and safe workplace. Follow the SOP practices. Preparation to comply statutory audit, customer audit and regulatory audit. Batch charging and process work out as per written instruction. Shift handover / instruction/ information communication. Operation & cleaning of Equipments. Suggests changes in working conditions and use of equipment to increase efficiency of equipment. Initiates or suggests plans to motivate workers to achieve work goals. Maintaining cleanliness and hygienic practices in the plant premises.

Monitor and control batch processes and chemical reactions under supervision. Maintain accurate production records, logbooks. Ensure compliance with safety protocols and environmental guidelines. Basic understanding of organic and inorganic chemistry

Role & responsibilities Cell Culture & Production Support: Perform aseptic handling and maintenance of cell cultures (e.g., Vero, BHK or other cell lines) in adherent and/or suspension formats. Prepare and sterilize culture media, buffers, and reagents as per batch requirements and SOPs. Monitor and record cell growth parameters, viability, and morphology. Scale-up cell cultures for downstream processing or viral seed production. Facility & Environmental Monitoring: Conduct routine facility checks including temperature, humidity, pressure differentials, and cleanroom conditions. Coordinate and ensure compliance with environmental monitoring schedules (viable/non-viable particles, surface, and air sampling). Assist in maintaining facility readiness and hygiene per cGMP standards. Documentation & Quality Compliance: Prepare and review SOPs, batch manufacturing records (BMRs), logbooks, and calibration/maintenance records. Maintain data integrity and compliance with Good Documentation Practices (GDP). Participate in internal and external audits, ensuring timely closure of CAPAs. Quality Management System (QMS): Support implementation and maintenance of QMS elements: deviations, change controls, CAPA, risk assessments, and document control. Participate in training programs related to QMS and GMP compliance. Working knowledge of QMS software/tools is an added advantage. Desired Skills: Proficiency in aseptic techniques and cleanroom operations. Strong understanding of GMP, GLP, GDP, and ISO standards. Good written and verbal communication skills. Job Location: Kadi, Gujarat ( Bus facility available from Ahmedabad, Kalol & Kadi)

Role & responsibilities Job summary We are looking for an individual to perform filling/washing and sterilization operations within GMP (Good Manufacturing Practices), regulatory, and organizational guidelines. The objective is to produce products within defined volumes and timelines, ensuring compliance with quality standards, GMP, and regulatory requirements as per schedule. " Roles & Responsibilities Perform filling, washing, sterilization operations as per the day plan, executing batch production records. Participate in filling area line clearance activities and perform machine cleaning operations. Handle material dispensing and issuance from the warehouse. Issue discrepancies, work with cross-functional departments to close discrepancies, and implement appropriate corrective actions. Compliance with GMP, safety standards, and SOPs (Standard Operating Procedure) for designated manufacturing equipment. Maintain records in machine operation log books. Maintain manufacturing equipment to ensure correct functionality and calibration compliance. Actively engage in validation and qualification activities for all manufacturing area machines. Promote safety awareness and improvements, engage in continuous improvement activities, and adhere to the company's safety rules. Report all unsafe matters, near misses, and accidents. Preferred candidate profile Educational qualification and work experience Educational qualification: A Diploma or B.Pharm. Minimum work experience: 4 to 6 years of experience in batch formulation operations Skills & attributes Technical Skills Proficiency in comprehending and overseeing sterile and fill finish operations in pharmaceutical manufacturing, demonstrating familiarity with the processes involved. Practical experience and hands-on knowledge in executing sterile and fill finish operations, showcasing the ability to actively participate in and manage these critical manufacturing processes. Practical expertise in equipment validation, process validation, and cleaning validation, demonstrating the ability to validate and ensure the reliability of manufacturing equipment and processes. Behavioral skills Effective listening skills, ensuring a comprehensive understanding of information. A keen eye for detail, ensuring accuracy and precision in tasks. Awareness and sensitivity to deadlines, ensuring timely completion of tasks. Analytical skills and the ability to troubleshoot, enabling effective problem-solving. Strong interpersonal skills and the ability to work well in a team, fostering collaboration and positive team dynamics. Location: Pydibhimavaram Dr Reddy's Formulations Limited(DFL-02) Injectable Facility, Aseptic Manufacturing Hiring For : Filling,Compounding,Autoclave,Lyo Operators, PM(Preventive Maintenance),Documentation, MS Office

Job Description: Operate, monitor, and optimize chemical production processes. Prepare chemical batches according to Standard Operating Procedures (SOPs). Ensure quality control through in-process testing. Coordinate with Quality Assurance (QA) and R&D teams for process improvement and new product trials. Maintain production documentation, including batch records, logbooks, and reports. Adhere to safety protocols, chemical handling procedures, and environmental regulations. Troubleshoot equipment malfunctions and process deviations. Support in scaling up lab-scale processes to full-scale production. Monitor inventory levels of raw materials and reagents. Train and guide plant operators and junior chemists. Apply knowledge of chemical plant operations, instrumentation, and safety standards. Ensure compliance with Good Manufacturing Practices (GMP), ISO standards, and relevant regulatory requirements. Key Skills & Competencies: Strong understanding of chemical processes and reactions Analytical and problem-solving skills Proficient in using lab and production equipment (e.g., reactors, mixers, dryers) Basic computer skills (MS Office, ERP systems) Effective communication and teamwork Required Qualifications: Education: B.Sc. / M.Sc. in Chemistry, Industrial Chemistry, Chemical Engineering, or a related field Experience: 15 years for entry to mid-level roles 5+ years for senior roles in chemical or pharmaceutical manufacturing Additional Information: At Avid Organics, we believe that we can achieve our mission to enhance value creation for our stakeholders only through the quality and commitment of our people. We continuously strive to unleash the potential of each individual. We leverage human capital for competitiveness by nurturing knowledge, entrepreneurship, and creativity. These strengths help us compete successfully in a global business environment and exploit emerging opportunities. We reward the will to succeed and the desire to compete with the best in the world. Our employees are intellectually stimulated and given the freedom to make their own decisions, driving our growth through innovation and experimentation. Apply Now! :- hr@avidorganics.net Visit our website or contact us at https://www.avidorganics.net Job Location: Survey No. 460/1,,,GEB SUB STATION ROAD,,POICHA-Ra nia, Ta.- Savli , VADODARA, Gujarat, India

Responsibilities: * Oversee batch manufacturing & processing * Ensure chemical quality & safety standards met * Coordinate production schedules & resources allocation Log Sheet Verification: Regularly check and verify log Health insurance Annual bonus