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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 12 hours ago
2.0 - 6.0 years
0 Lacs
krishnagiri, tamil nadu
On-site
As a Shift Executive at our Krishnagiri location, you will be responsible for efficiently managing the shift manpower to enhance productivity. Your primary duties will include ensuring the timely completion of the day's production schedule, monitoring processes, conducting in-process checks, and coordinating with other departments to achieve the desired output. Additionally, you will be tasked with maintaining production records, optimizing yield, streamlining workflow to minimize downtime, and planning preventive maintenance activities. Training and developing both migrant and new manpower will be crucial aspects of your role, along with overseeing housekeeping practices, ensuring compliance with Good Manufacturing Practices (GMP), and implementing the 5S methodology to uphold a safe working environment. Ideally, you should possess 2-5 years of experience, with a background in Bakery and Confectionery being an added advantage. A Bachelor's degree in Food Technology, Mechanical, or Electrical Engineering (B.E/B.Tech) is required to qualify for this position. If you are a proactive individual with excellent organizational and leadership skills, we encourage you to apply and contribute to our team's success.,
Posted 1 day ago
1.0 - 5.0 years
0 Lacs
ahmedabad, gujarat
On-site
The core job responsibilities for the position holder include: Responsible for operating, cleaning, and performing primary maintenance on negative isolator, Vibro sifter, Bin blenders, and all other GEA granulation line equipment. This includes recording activities in logbooks, Batch manufacturing records, and completing documentation required for product manufacturing and equipment cleaning, while following cGMPs and good documentation practices. Performing all in-process checks and monitoring of intermediate processes in granulation. Selecting recipes and setting process parameters in Blender HMI, ensuring correctness before blender operation. Issuing, utilizing, cleaning, and retrieving sieves, as well as handling machine change parts inventory appropriately. Setting up, changing over, and operating various manufacturing equipment within the granulation department. Reporting or escalating any conditions or problems that may impact product quality or integrity to the supervisor and HOD production. Maintaining a neat, clean, and safe working environment at all times, and promptly notifying the supervisor of any safety concerns, accidents, or injuries observed. Conducting in-process checks and monitoring of intermediate processes, verifying process parameters in PLC/SCADA according to BMR before machine operation in the granulation area. Ensuring compliance with current Good Manufacturing Practices in the Hormone Facility and following GDP with data-integrity compliance. Completing training and training records within the stipulated time frame. Preparing and utilizing disinfectant and cleaning agent solutions following defined procedures. Adhering to all company policies, procedures, SOPs, and safety regulations.,
Posted 1 week ago
1.0 - 5.0 years
0 Lacs
ahmedabad, gujarat
On-site
The core job responsibilities of the position holder include: Responsible for the operation, cleaning, and primary maintenance of negative isolator, Vibro sifter, Bin blenders, and all other GEA granulation line equipment. Record activities in logbooks, Batch manufacturing record & complete documentation following cGMPs and good documentation practices. Perform all in-process checks and monitoring of intermediate processes in granulation. Select recipes, set process parameters in Blender HMI, and ensure correctness before blender revolution. Issue, utilize, clean, and retrieve sieves and handle machine change parts with inventory. Set up, changeover, and operate various manufacturing equipment in the granulation department. Report or escalate any conditions or problems affecting product quality to supervisor and HOD production. Maintain a neat, clean, and safe working environment, reporting safety concerns, accidents, or injuries to the supervisor immediately. Conduct in-process checks, monitor intermediate processes, set process parameters in PLC/SCADA per BMR before machine run in granulation area. Ensure compliance with current Good Manufacturing Practices in the Hormone Facility and follow GDP with data-integrity compliance. Complete training and training records within stipulated time. Prepare and use disinfectant and cleaning agent solutions following defined procedures. Adhere to all company policies, procedures, SOPs, and safety regulations.,
Posted 1 week ago
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