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3.0 - 7.0 years
0 Lacs
hyderabad, telangana
On-site
As a diligent team member, you are required to adhere to safety regulations within the premises as per company guidelines. Your responsibilities include conducting in-process checks during operations. You will be accountable for operating and cleaning various machines such as the Wrap-around labeling machine, Autocartonator machine, Online check weigher, track and trace system, Bopp taping machine with weighing balance, and machines in the PFS packing area. Additionally, you will be in charge of dispensing, checking, and receiving packing materials from the warehouse as needed. Your duties will also involve labeling and packing products according to the Batch Production Record (BPR). Timely completion of calibrations and validations in collaboration with EN and QA for visual inspection and packing area activities is also part of your role. Operating and cleaning equipment like the visual inspection table, Lux meter, Automatic visual inspection machine, and X-RAY inspection machine fall under your purview. You will need to coordinate with various departments, including QA, QC, warehouse, Engineering, MB, HR, and administration for daily operations. Conducting visual inspections of products, performing in-process checks, and handling decartoning activities are crucial aspects of your responsibilities. Completing SOPs training, on-the-job trainings related to visual inspection and packing areas, and maintaining cleanliness in the visual inspection and packing regions are essential duties. Monitoring DP, RH, and temperature in the visual inspection and packing areas, as well as maintaining BMRs and other logbooks in compliance with cGMP and SOP, are also part of your role. Qualifications: - B.Pharmacy or M.Pharmacy - Experience: 3 to 5 years,
Posted 1 day ago
10.0 - 15.0 years
0 Lacs
bengaluru, karnataka, india
On-site
Date: 12 Aug 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Manufacturing Services Designation: Assistant Manager Job Location: Bangalore Reporting to: Deputy Manager Job Grade: 8-II The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngenes 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. Key Result Areas Role-specific Provide input to Downstream for improvement of products/process. Develop and train high potential candidates for the next generation of leaders. Serve as a mentor to develop other leaders within the department. Downstream batch plan preparation as per campaign schedule. Supervise commissioning and qualification activity of BMP1 DSP related equipment. Preparation of micro batch schedule and shift planning for day-to-day activities. Monitor and follow good aseptic behavior inside the BMP1 facility. Support in audit and audit closure points. Involve in shipment of samples / final product as per packing and dispatch record. Preparation of BMRs, SOPs,IOPs & EOPs,general validation protocols and reports, equipment requalification protocols, Installation, operation and performance qualification protocols and related documents. Supervise Downstream activities of buffers preparation, Harvest, purification and final filtration, Calibration of operations equipment. Monitoring and process control of specific operations of downstream. Compliance to current good manufacturing practices. Preparation and periodic revision of equipment cleaning checklist (ECC)as ad when required. Perform room owner responsibility for the assigned DSP area. Maintain facility and assigned zone all-time ready for visit and audit. Involve in Shipment of samples /final product as per packing and dispatch record. Review of executed Documents on time. Education and Experience Education Graduate or Masters degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field. Industry Experience Minimum 10 - 15 years of relevant practical experience in Downstream process Production for biopharmaceuticals, specifically with CHO cell lines for monoclonal antibodies, fusion proteins, etc. Other Competencies Required For The Role NA Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Pls visit us at https://syngeneintl.com/ to know more about us and what we do. Show more Show less
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
ahmedabad, gujarat
On-site
You will be responsible for preparing and reviewing the master documents of sterile manufacturing for the parenteral facility. Additionally, you will prepare and review protocols and reports based on the specified requirements. Document management and preparation tasks such as BMRs, BPRs, and master SOPs will also fall under your responsibilities. Handling change control, deviations, CAPA, investigations, and providing training to subordinates, technicians, and operators within the department are key aspects of this role. You will also be accountable for audit and compliance on the manufacturing shop floor. The ideal candidate for this position should hold a B.Pharm/M.Pharm degree and possess a minimum of 3-5 years of experience in manufacturing QMS, process review, and compliance. Knowledge of Kaizen and continuous improvement methodologies will be an advantage.,
Posted 2 weeks ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
The Manufacturing Department is looking for a candidate to monitor and execute production activities during the shift. The main aim is to maintain cGMP and safety norms to achieve production targets effectively. Key responsibilities include executing production activities in a shift by managing available resources to meet production targets. It is essential to maintain standard process parameters as per BMRs and other supporting documents to ensure quality production. Additionally, preparing manufacturing records and updating online documentation to comply with production and cGMP requirements is crucial. Ensuring safe work processes and utilizing safety appliances during production activities is essential to create a secure working environment. The candidate should have a Bachelor's degree in Pharmacy and at least 2 years of experience in pharmaceutical manufacturing. The ideal candidate should possess competencies such as collaboration, innovation, accountability, empathy in leadership, agility, strong domain knowledge, and people management skills. The job location is Bommasandra, and the role involves shift hours.,
Posted 3 weeks ago
3.0 - 7.0 years
0 Lacs
telangana
On-site
You will be responsible for managing all Quality Management System (QMS) activities related to production. It is crucial to ensure that batch charging and other manufacturing operations strictly adhere to the Batch Manufacturing Record (BMR) and Standard Operating Procedures (SOP), aligning with current Good Manufacturing Practices (GMP). Your duties will include maintaining manufacturing records online, collecting samples of intermediate materials, entering production-related data into the SAP system, and verifying the generation of PISCADA reports. Additionally, you will be tasked with overseeing finished goods transfer, monitoring stock levels of consumables, coordinating with various service departments, and ensuring preventive maintenance of equipment. Safety is a top priority, and you must follow safety procedures, attend training sessions, conduct staff training, and report any incidents promptly. As part of your role, you will manage the allocation of Isoflurane bulk to customers, participate in initiatives like AET and CSR, and perform senior duties in their absence. It is essential to prepare and execute operational protocols, SOPs, and maintain documentation accurately. Your attention to detail is crucial in handling tasks such as DocuSign and tracking related activities. Qualifications: - B.E / B.Tech in Chemical Engineering About The Team: Piramal Critical Care (PCC), a subsidiary of Piramal Pharma Limited (PPL), is a global player in hospital generics, specializing in Inhaled Anaesthetics. With a commitment to delivering critical care solutions worldwide, PCC aims for sustainable growth and stakeholder satisfaction. The team operates across the USA, Europe, and over 100 countries, offering a diverse product portfolio and maintaining high-quality manufacturing facilities. PCC values corporate social responsibility and collaborates with partner organizations to support communities and the environment. As part of the Piramal Group, PCC upholds ethical practices and inclusive growth, providing equal opportunities for all employees based on merit and performance.,
Posted 3 weeks ago
1.0 - 3.0 years
0 - 3 Lacs
Kolkata, West Bengal, India
On-site
Job description 1.Participate and adhere in all EHS continual improvement line responsibilities (Eg. Emergency mock drill 2.participation, training, permit to work, etc.) and responsibilities mentioned in the site EHS procedures. 3.Follow all the site safety requirements and exhibit positive behavior in the safety culture transformation. 4.Follow the all permit to work procedure in shop-floor activities. 5.Follow the required Personnel Protective equipment (PPE) usages during performing the shop-floor operations. 6.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. 7.Follow the previous shift s information / Manager s instructions and complete the assigned tasks, on time. 8.Ensure that executed BMRs, BPRs, ECRs review timely and submit to QA, as soon as possible, based on the requirement. 9.Review update the shop-floor documents contemporaneously i.e. BMRs, BPRs, ECRs, Logbooks, Protocols, Reports, Checklists, etc. 10.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. 11.Impart the trainings on SOPs, revised documents qualification protocols/ reports to shop-floor personnel. 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
Posted 3 weeks ago
1.0 - 3.0 years
0 - 3 Lacs
Hyderabad, Telangana, India
On-site
Job description 1.Participate and adhere in all EHS continual improvement line responsibilities (Eg. Emergency mock drill 2.participation, training, permit to work, etc.) and responsibilities mentioned in the site EHS procedures. 3.Follow all the site safety requirements and exhibit positive behavior in the safety culture transformation. 4.Follow the all permit to work procedure in shop-floor activities. 5.Follow the required Personnel Protective equipment (PPE) usages during performing the shop-floor operations. 6.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. 7.Follow the previous shift s information / Manager s instructions and complete the assigned tasks, on time. 8.Ensure that executed BMRs, BPRs, ECRs review timely and submit to QA, as soon as possible, based on the requirement. 9.Review update the shop-floor documents contemporaneously i.e. BMRs, BPRs, ECRs, Logbooks, Protocols, Reports, Checklists, etc. 10.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. 11.Impart the trainings on SOPs, revised documents qualification protocols/ reports to shop-floor personnel. 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
Posted 3 weeks ago
4.0 - 8.0 years
0 Lacs
Mumbai, Maharashtra, India
On-site
Be the First to Apply Job Description Business: PPL Digwal Department: Production Location: Digwal Job Overview: To perform Production actives as per GMP & Safety Travel Requirements : NA Reporting Structure Reports to Manager - Production Key Stakeholders Internal: QC, QA, SCM & Safety External: NA Experience 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities 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 shifts information / Managers 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 Qualification : B.Sc (Chemistry) / M.Sc (Chemistry) / 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 Limiteds 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. Job Info Job Identification 9139 Job Category Production Posting Date 07/29/2025, 09:26 AM Apply Before 08/06/2025, 09:26 AM Degree Level Bachelor&aposs Degree Job Schedule Full time Locations Piramal Enterprises Limited. Factory: Digwal, Medak, Telangana, 502321, IN Show more Show less
Posted 4 weeks ago
4.0 - 8.0 years
0 Lacs
Mumbai, Maharashtra, India
On-site
Be the First to Apply Job Description Business: PPL Digwal Department: Production Location: Digwal Job Overview: To perform Production actives as per GMP & Safety Travel Requirements : NA Reporting Structure Reports to Manager - Production Key Stakeholders Internal: QC, QA, SCM & Safety External: NA Experience 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities 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 shifts information / Managers 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 Qualification : B.Sc (Chemistry) / M.Sc (Chemistry) / B.Tech (Chemical) Job Info Job Identification 5304 Posting Date 07/29/2025, 06:28 AM Apply Before 08/04/2025, 06:28 AM Degree Level Technical Diploma/A Level Job Schedule Full time Locations Piramal Enterprises Limited. Factory: Digwal, Medak, Telangana, 502321, IN Show more Show less
Posted 4 weeks ago
4.0 - 8.0 years
0 Lacs
Mumbai, Maharashtra, India
On-site
Be the First to Apply Job Description Business: PPL Digwal Department: Production Location: Digwal Job Overview: To perform Production actives as per GMP & Safety Travel Requirements : NA Reporting Structure Reports to Manager - Production Key Stakeholders Internal: QC, QA, SCM & Safety External: NA Experience 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities 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 shifts information / Managers 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 Qualification : B.Sc (Chemistry) / M.Sc (Chemistry) / 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 Limiteds 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. Job Info Job Identification 9138 Job Category Production Posting Date 07/29/2025, 09:15 AM Apply Before 08/06/2025, 09:15 AM Degree Level Bachelor&aposs Degree Job Schedule Full time Locations Piramal Enterprises Limited. Factory: Digwal, Medak, Telangana, 502321, IN Show more Show less
Posted 4 weeks ago
8.0 - 10.0 years
1 - 2 Lacs
Ankleshwar
Work from Office
Approving all Specifications, Test Methods, and Batch Process and Control Records (BMRs). approving validation protocols and reports, and conducting the General Good Manufacturing Practices (GMP) training.
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
vadodara, gujarat
On-site
The Quality Assurance (QA) Executive API (Bulk Drugs) role based in Savli, Gujarat requires a candidate with 2-5 years of experience and a qualification of B.Sc / M.Sc. As a QA Executive, your responsibilities will involve ensuring compliance with cGMP, ICH, and regulatory guidelines in API (bulk drug) manufacturing. You will be responsible for preparing, reviewing, and controlling SOPs, BMRs, BPRs, change controls, deviations, and CAPAs. In addition, conducting in-process checks for manufacturing and packaging activities, handling investigations for deviations, OOS/OOT results, and supporting root cause analysis are key components of this role. You will also be involved in participating in internal audits, regulatory audits (USFDA, EU, WHO, etc.), and vendor audits. Maintaining documentation for batch release, validation protocols, and quality systems, ensuring adherence to data integrity and good documentation practices (GDP), and supporting qualification and validation activities are crucial aspects of this position. Collaboration with cross-functional teams such as Production, QC, and R&D is essential for ensuring smooth operations. This is a full-time, permanent position with benefits including health insurance and Provident Fund. The work schedule is day shift with additional perks such as performance bonus and yearly bonus. The work location is in person.,
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
The Company Syngene International Ltd. is an integrated research, development, and manufacturing solutions company serving various sectors including pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemicals. With a team of over 4500 scientists, Syngene offers expertise in delivering high-quality science, robust data management, IP security, and efficient manufacturing processes. The company's facilities span over 1.9 million square feet, catering to leading biotech companies and multinational corporations such as GSK and Merck KGaA. Key Responsibilities Safety is a top priority at Syngene, and all employees are expected to prioritize safety in both personal and professional capacities. Compliance with safety guidelines, procedures, and SOPs is mandatory to ensure a safe work environment. Common Responsibilities - Adhere to Environment, Occupational Health, Safety, and Sustainability (EHSS) practices for a safe work environment. - Complete assigned trainings in a timely manner and comply with training procedures. - Participate in mandatory trainings related to data integrity, health, and safety. - Maintain compliance with Good Manufacturing Practices and Good Documentation Practices. - Follow Standard Operating Procedures and Operational Control Procedures. - Support training programs on procedures, protocols, and on-the-job activities. - Report nonconformities and deviations to supervisors or line managers promptly. - Participate in deviations, investigations, CAPA, and change controls as needed. Safety And DI Responsibilities - Follow organizational policies on EHSS, POSH, Data Integrity, and IT security. - Wear applicable Personal Protective Equipment (PPE) and adhere to EHS requirements. - Understand and follow safety protocols to prevent incidents. - Identify near-misses and potential incidents, and report them to supervisors. Specific Responsibilities - Adhere to aseptic behavior in Biologics operations. - Perform upstream activities including Assembly preparation, Media Preparation, Vial thaw, Feed preparation, and Bioreactor Operations. - Monitor and control specific Operations of the upstream processes. - Maintain Quality records and traceability of products. - Perform in-process product sampling and storage. - Review and prepare operation-related documents. - Take responsibility for the assigned USP area and equipment/instrument ownership. - Coordinate with QA for line clearance and maintain process areas for inspections. - Prepare procedures, protocols, risk assessments, and Batch Manufacturing Records (BMRs). - Execute protocols related to upstream activities and equipment/instrument qualification. - Review consumable stock and maintenance records. - Ensure timely closure of work orders and report nonconformities. - Participate in downstream activities under the supervision of downstream supervisors. Syngene International Ltd. is an Equal Opportunity Employer. Visit https://syngeneintl.com/ to learn more about the company and its operations.,
Posted 1 month ago
8.0 - 13.0 years
5 - 7 Lacs
Ankleshwar, Gujrat, India
On-site
Role & responsibilities To take plant round and monitor production activities at shop floor. To prepare appropriate Quality related documents like SOP, BMR, BCR, BPR etc. To review BMRs, BCRs, and analysis records before release of API. To perform sampling of API's and maintain its records. To maintain control samples of API and its records. To perform and ensure the cleaning of sampling tools. To provide line clearance at the time of product changes over. To review dispatch of finished product and maintain record for the same. To Investigate the deviations identified in co-ordination with QA-Head/Designee. Product quality review of API Process and cleaning validation monitoring in plant
Posted 1 month ago
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