1019 Cgmp Jobs - Page 14

What you will do In this vital role you will provide technical expertise and product leadership to the Product Quality (PQ) organization. As a product support staff in Quality, the Product Quality Specialist has responsibility for working with Product Quality Leaders (PQL), International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other groups on projects including support of product specifications, in-process controls, periodic and annual product review, and complaint resolutions. Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of t...

This role will support one or more late-stage and/or commercial biologics or synthetics products. The individual will provide project support to the relevant Product Quality Team (PQT) to implement and manage strategy for Quality to meet the Product Quality goals. The individual will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments, periodic and annual product reviews (APR). In addition, the candidate will be expected to pla...

Role & responsibilities Location: Bidar, KA Role: Sr QA Lead JOB DESCRIPTION: 1) Handling of Quality management system. 2) Monitoring Process validation program. 3) Handling of customer and regulatory audits. 4) Monitoring Equipment Qualification program. 5) Coordinate with cross functional team to provide audit response to customer and regulatory agencies. 6) Conducting internal audits as per schedule. 7) CAPA effectiveness verification. 8) Conducting Quality review board meetings and management review meetings as per schedule. 9) Monitoring Equipment cleaning program. 10) Providing necessary documents to address Regulatory Queries, amendments, annual updates and regulatory filings and CMC ...

.. the , Position Title: QA Chemist (Team Member) Company Name: Sinterx Pharma Private Limited Location: Valigonda, Choutuppal. Description: The QA Chemist with 5 to 8 years of experience is responsible for ensuring that all API intermediate manufacturing operations comply with established quality standards, GMP requirements, and regulatory guidelines. This role involves reviewing and approving GMP documentation, overseeing batch records, managing deviations and CAPA, conducting internal audits, and ensuring continuous compliance across the production lifecycle. The QA Chemist will collaborate with cross-functional teams including Production, QC, and R&D to maintain quality excellence and su...

Hi, Greetings from Avani Consulting!! We have job opportunities with API Manufacturing Company for the Sr. Executive/Executive- Electrical position, Mysore Location. Position- Sr. Executive/Executive- Electrical & Instrumentation Work Experience +8 in API / Pharmaceutical / Chemical / FMCG / Continuous Process Industry Location Mysore Qualification- B.E. / B.Tech / Diploma in Electrical Engineering. Knowledge of SAP. Must Have Electrical Supervisor License Must have experience in 66KV Job Summary: To lead and manage all electrical maintenance activities and ensure optimal performance, reliability, and safety of electrical systems in an API manufacturing facility. The role also includes effic...

Followings will be the Core Job Responsibilities of the position holder: 1. Responsible for Operation, cleaning and primary maintenance of negative isolator, Vibro sifter, Bin blenders and all other GEA granulation line equipment. 2. Responsible for recording of activity in logbooks, Batch manufacturing record & complete documentation as required in the manufacturing of product and the cleaning of facilities and equipment, following cGMP's and good documentation practices. 3. To perform all in-process checks and monitoring of all intermediate processes in granulation. 4. To select recipes and set process parameters in Blender HMI & ensure its correctness before blender revolution. 5. Respons...

Division Department Sub Department 1 Job Purpose Execute analysis of allocated samples and Produce reliable and reproducible results in order to ensure their compliance to the microbiological quality parameters and predefined specifications and standards. Key Accountabilities (1/6) Analyse and review samples based on work allocation to meet the service level agreement Analyse samples as per priority and work allocation Review the data as per respective specification, Microbiological Methods and results obtained Prepare, review and submit reports to Team leader within stipulated timelines in order to support individual sample release within stipulated timelines to achieve SLA Key Accountabili...

Division Department Sub Department 1 Job Purpose Execute analysis of allocated samples and Produce reliable and reproducible results in order to ensure their compliance to the microbiological quality parameters and predefined specifications and standards. Key Accountabilities (1/6) Analyse and review samples based on work allocation to meet the service level agreement Analyse samples as per priority and work allocation Review the data as per respective specification, Microbiological Methods and results obtained Prepare, review and submit reports to Team leader within stipulated timelines in order to support individual sample release within stipulated timelines to achieve SLA Key Accountabili...

Responsible to work as per cGMP and maintain the compliance requirement. Responsible to develop the method for Extractable and Leachable compounds. Responsible to perform method validation & verification on different technique for E&L related work. Responsible to perform extractable & leachable(s) study for different packaging materials by using different analytical techniques like GC/GC-MS, HPLC/LC-MS, ICP/ICP-MS, IR, UV and other relevant techniques. Responsible to perform Identification, Investigation and troubleshooting task. Responsible to perform chemical analysis like, Extraction, Refluxing, Residue on ignition, Centrifuging & Evaporation etc. Responsible to prepare the study template...

Job Title Sr Executive/Manager 2 Business Unit Sun Global Operations Job Grade G11B/G11A Location : Guwahati At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Key Responsibilities Responsible for Receipt of Raw, Packing & Misce...

To work as per cGMP and ensure its compliance as per current guideline and SOPs. Responsible to take training before execution of allotted work & maintaining the training file. Responsible to follow safety precaution as per laboratory procedure. Responsible to escalate any issue / incident to reporting manager for prompt corrective action. Responsible for method development studies of API, Drug Product & In process Material preferably Peptide molecules Responsible for method Validation studies of API, Drug Product & In process Material preferably Peptide molecules Responsible for routine and stability studies of API, Drug Product & In process Material preferably Peptide molecules Responsible...

Job Title DGM Operations (Sterile) Business Unit Sun Global Operations Job Grade G8 - DGM Location : Halol Key Responsibilities At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Key Responsibilities Approving sign authority for...

To work as per cGMP and ensure its compliance as per current guideline and SOPs. Responsible to take training before execution of allotted work & maintaining the training file. Responsible to follow safety precaution as per laboratory procedure. Responsible to escalate any issue / incident to reporting manager for prompt corrective action. Responsible for method development studies of API, Drug Product & In process Material preferably Peptide molecules Responsible for method Validation studies of API, Drug Product & In process Material preferably Peptide molecules Responsible for routine and stability studies of API, Drug Product & In process Material preferably Peptide molecules Responsible...

This is where your work makes a difference. At Baxter, we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. He...

Job Description Maintaining work place-good housekeeping as per cGMP Operating and cleaning of equipment as per SOP Receipt and storage of raw material in day stock area for the batch as per request slip Carry out the process as per LMR and operation verification All safety rules/precaution to be followed strictly Execution of the production schedules for current and coming months Coordinating internal /external audits and maintaining relevant documents In process checks to be done and documented in presence of supervisor Maintaining cGMP standards, ISO 9001, ISO 14001 & HACCP standards in the plan Making sure that the premises and equipment are maintained and records kept Responsibility in ...

Role & responsibilities Operate aerosol filling and packaging machinery including spray dryers, capsule filling, blister packing, and secondary packaging equipment Perform weighing, blending, dispensing, mixing, granulating, drying, and coating processes as per batch production records Conduct machine changeovers and setup for different product batches. Monitor equipment parameters and ensure operations are within defined specifications. Ensure compliance with SOPs, cGMP, and regulatory requirements. Participate in audits and inspections as required. Perform routine equipment cleaning and maintenance. Assist in troubleshooting and resolving equipment issues.

Roles and Responsibilities 1. Responsible for implementation & monitoring of cGMP/GDP practices at site. 2. Responsible for periodic review of all quality Documents for appropriateness. 3. Preparation of SOPs and handling of QMS tools like deviation change control, CAPA. 4. Responsible for approval/rejection of deviations /change controls pertaining to corporate activities. 5. Oversee the team of technical personnel handling order processing artworks finalization BOM updating of products and follow ups. 6. Responsible for co-ordination and submission of Quality documents for regulatory submissions. 7. Responsible for maintenance, periodical update and review of technical agreements with dome...

You will be joining Piramal Pharma Solutions HPAPI Research and Manufacturing facility in Riverview, Michigan as a (Senior) Process Development Scientist. Your primary responsibility will be to provide analytical support to the stability and reference standard programs. Key Responsibilities: - Develop, conduct, and manage the process development of current and new synthetic/process pathways. - Maintain communication with clients to ensure their requirements are met. - Manage the production of new APIs, ensuring the availability of necessary materials and equipment. - Ensure product shipments meet customer and regulatory requirements. - Write progress reports and provide technical support in ...

Role Overview: You will be responsible for visual inspection and packing activities in the designated area. Your primary duties will include operating machines, cleaning and sanitizing the work area, performing packing-related tasks, and maintaining accurate documentation. Key Responsibilities: - Conduct visual inspection and packing tasks according to standard operating procedures. - Operate machines efficiently and effectively. - Maintain cleanliness and sanitation in the visual inspection and packing area. - Complete all packing-related activities as required. - Keep detailed logs of activities and observations. - Attend training sessions as scheduled and ensure compliance with the traini...

Roles and Responsibilities Conduct quality control analysis using HPLC, GC, UV, spectrophotometer, sterile techniques, and other relevant methods. Ensure compliance with USFDA, GMP, GLP regulations during regulatory audits. Develop and maintain SOPs for laboratory operations and testing procedures. Collaborate with cross-functional teams to resolve quality issues and improve processes. Perform stability studies on APIs and finished products as required. Desired Candidate Profile 2-7 years of experience in a pharmaceutical industry setting with expertise in QC analysis. MS/M.Sc(Science) degree in Chemistry or related field; Strong understanding of analytical instruments such as HPLC, GC, UV s...

Roles and Responsibilities Ensure compliance with GLP guidelines, including investigation of OOS/OOT events and vendor qualification. Maintain accurate records of GLP documents, instruments, and equipment through preventive maintenance schedules. Conduct calibrations on instruments according to CGMP requirements and perform spares management tasks. Implement LIMS system for effective inventory control and HPLC analysis. Perform CAPA activities as needed to resolve quality issues. Desired Candidate Profile MS/M.Sc(Science) degree in Chemistry or Organic Chemistry from a recognized university. Minimum 10-15 years of experience in pharmaceutical industry with expertise in GLP practices. Strong ...

As a candidate for this role, you will be responsible for various tasks related to self-hygiene and the sterile manufacturing department. Your key responsibilities will include: - Updating on self-hygiene - Preparation, review, revision, control, and implementation of standard operating procedures - Preparation and review of protocols and reports - Document management including BMRs, BPRs, Master SOPs, etc. - Handling of Change Control, Deviations, CAPA, Investigation - Generating general purchase indents for departmental items - Preparation of production planning on a monthly and daily basis - Preparation of daily production reports - Ensuring validation and calibration status of equipment ...

As a Production Operator at ACG Group Company in Dahanu, India, your primary responsibilities will include: - Checking the allocated post production (ATS/Printing/camera) line(s) in each shift as per the CTQ (critical to Quality) /CTP (Critical to Productivity) checklist. - Following the plan as per color change note by ensuring minimal change over time at each sub section. - Following instructions from the shift lead for timely change over by ensuring availability of roller(s)/ink etc. - Executing IPQC after every roller cleaning and checking of rejections of camera(s) after every hour to achieve zero defects. - Operating cameras as per SOP to achieve productivity and quality. - Coordinatin...

Regulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profile BSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier prep, submission processes, documentation, compliance, MS Office, attention to detail & communication skills.

Handle the Recovered Section. Assist in investigations related to out-of-specification (OOS), deviations, and laboratory incidents. Review and verify entries in logbooks, worksheets, and other controlled documents. Required Candidate profile Review analytical raw data, calculations, and reports for accuracy, completeness, and compliance with approved specifications and methods. Ensure all laboratory documentation meets regulatory