17 Bprs Jobs

As the Packing and Visual Inspection Supervisor in the fill-finish area, your role involves overseeing the packing and visual inspection operations. Your key responsibilities will include: - Supervising overall packing and visual inspection operations in the fill-finish area. - Preparing and maintaining GMP documentation such as SOPs, BPRs, protocols, reports, and equipment qualification documents. - Ensuring all fill-finish packing equipment is installed, qualified, and maintained in operational condition. - Managing material inventory to ensure timely availability for packing operations. - Planning and executing batch packing activities according to production schedules. - Performing opera...

As a Process Development Scientist, your role involves the planning and execution of microbial fermentation and purification processes for polysaccharides and proteins. This includes utilizing techniques such as Tangential flow filtration (TFF), Chromatography, and sterile filtration. You will also be responsible for preparing scale-up and scale-down study plans for tech-transfer and troubleshooting purposes. Your key responsibilities will include: - Executing scale-up and scale-down experiments for Manufacturing Science & Technology, ensuring oversight throughout the process. - Designing experiments, planning project timelines, and ensuring timely completion of all assigned projects. - Coor...

Best fit profile Knowledge in handling and troubleshooting purification methods at small scale and pilot scale Various Chromatography techniques like Ion exchange, Affinity, HIC etc. Ultrafiltration TFF (Hollow Fiber/Cassettes). Should be well versed with FPLC, AKTA- Process, AKTA- Pilot. Responsibilities Purification method development, optimization, & execution for bacterial & viral vaccines. Experience in Cell lysis, different chromatography platform, TFF system, Filtration unit and other unit operations used in protein purification. Purification method optimization and development for protein expressing in E.coli and mammalian cell culture. Execution of In House Calibration of AKTA Syste...

Supervise overall packing and visual inspection operations in the fill-finish area. Prepare and maintain GMP documentation , including but not limited to SOPs, BPRs, protocols, reports, and equipment qualification documents . Ensure all fill-finish packing equipment are installed, qualified, and maintained in operational condition. Manage material inventory and ensure timely availability for packing operations. Plan and execute batch packing activities in line with production schedules. Perform operation, verification, calibration, and cleaning of weighing balances (1.5 kg). Oversee labelling, packaging, and visual inspection activities , ensuring accuracy and compliance with GMP. Conduct vi...

Job Description Responsible for routine operations of power distribution system, D.G. Sets, HT Breakers, HT Yard, LT Breakers, switch gears and distribution panels. To Perform the preventive as per schedule and predictive maintenance as when required for all Electrical power distribution equipment's. To attend the breakdown maintenance of all Electrical power distribution equipment's like LT panels, D.G. Sets, HT Breakers, HT Yard, LT Breakers, and switch gears To attend the breakdown maintenance of Chillers, Air compressors, Boiler control system, Water system, cooling towers, and other utilities. To record daily log sheets related to Power distribution system SOPs and as instructed by supe...

Job Description: Planning & execution of microbial fermentation. Planning & execution of purification of polysaccharide and protein, including Tangential flow filtration (TFF), Chromatography & sterile filtration. Preparation of scale-up plan and scale-down study plan for tech-transfer and troubleshooting respectively. Execution (and oversight) of scale up & scale down experiment for Manufacturing Science & Technology. To ensure timely completion of all the projects assigned, experiment design, planning and execution of experiments. Interdepartmental co-ordination with DQA, DQC, Animal House, engineering & warehouse. Literature, research paper review and its implementation. Preparation of pr...

As a Manufacturing Specialist in our company, your responsibilities will include: - Performing line clearance activities before commencing operations to ensure a clean and sanitized visual inspection and Packing area - Following the preventive maintenance schedule of machines - Operating the machines efficiently and filling the log of general areas as per SOP and work execution - Adhering to cGMP, GDP, and maintaining discipline in the department - Ensuring that all employees comply with the same standards Your role will also involve: - Ensuring that all equipment and production lines are in validated and calibrated status - Preparing daily production reports based on achieved targets - Crea...

As a part of the Technology Transfer Team under the R&D vertical at Palli location, your primary responsibilities will include: - Preparing Master BMR and BPRs - Managing documents - Coordinating with various departments such as Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, and Engineering for the execution of Scale-up and Exhibit batches - Reviewing GMP related documents - Selecting equipment at the facility Your role will involve facilitating Change Controls for various reasons and initiating them due to revisions in BMR/BPRs and other PD related changes. You will also study critical parameters during scale-up batches to optimize the CPPs and CQAs, provi...

As a Process Development Scientist, you will be responsible for planning and executing microbial fermentation and purification processes for polysaccharides and proteins. This includes activities such as Tangential flow filtration (TFF), Chromatography, and sterile filtration. Your role will also involve preparing scale-up and scale-down study plans for tech-transfer and troubleshooting purposes. Key Responsibilities: - Plan and execute scale up and scale down experiments for Manufacturing Science & Technology. - Ensure timely completion of all assigned projects by designing, planning, and executing experiments effectively. - Coordinate with various departments such as DQA, DQC, Animal House...

You will be responsible for participating and adhering to all EHS continual improvement initiatives and line responsibilities such as emergency mock drill participation, training, permit to work, etc. It is crucial to follow all site safety requirements and demonstrate positive behavior in the safety culture transformation. You must adhere to the permit to work procedure during shop-floor activities and utilize the required Personnel Protective equipment (PPE) when performing operations. Identifying unsafe conditions or acts and promptly reporting them to the Manager/EHS team is essential, as well as reporting safety-related incidents, accidents, or illnesses to the OHC/Superiors/Manager imm...

You will be responsible for conducting line clearance activities before starting various operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. Additionally, you will perform environment monitoring activities and ensure compliance with cGMP at the shop floor. Your role will involve process validation, cleaning validation/verification, hold time study, media fill, routine batch sampling, and in-process testing at different stages according to batch documents and SOPs. You will review executed BMRs, BPRs, environment monitoring data, water trends, printouts (CIP, SIP, autoclave, filter integrity), and different types of planner and calibration certif...

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 posses...

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 a...

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 a...

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 a...

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 ...

Responsibilities: Initiation/Review of change control, impact assessment and management of change control records. Preparation of Annual Product Quality Review & MRM record. Review of Vendor questionnaire and related documents. Handling of deviation, market complaints, out of specification and CAPA. Review of Investigation of Deviation, OOS & Other Non-Conformities. Review Of Validation, Qualification CSV Document. interested candidates can share resume to hr3@sarthee.com or call at 9033033650