137 Cgmp Jobs - Page 6

PRODUCT QUALITY SPECIALIST What you will do Let’s do this. Let’s change the world. 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 the technologies we’re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients. 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 play a role in supporting Product Quality initiatives intended to ensure the overall product health. Support PQ work for late-stage and/or commercial biologic or synthetic programs, including actions required for the PQT, APR, specifications, comparability, stability programs, and PQ owned regulatory filing sections and responses to questions (RTQ) Support science and risk-based evaluation of complex process and product quality data such as in-process, release and stability data, complaints, method performance etc. What we expect of you Basic Qualifications and Experience: Doctorate degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 2 years of Quality, Operations, Scientific, or Manufacturing experience, or Master’s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 6 years of Quality, Operations, Scientific, or Manufacturing experience, or Bachelor’s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 8 years of Quality, Operations, Scientific, or Manufacturing experience or Preferred Qualifications: Must-Have Skills: Demonstrate proficiency in oral and written communication of complex information to Product Quality team members and peers Demonstrate proficiency in knowledge of cGMP and international regulatory expectations Strong scientific data management and organization skills with attention to detail Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems Ability to build and maintain multi-functional relationships and strong partnerships through written and verbal communication skills Good-to-Have Skills: Experience working virtually on a multi-functional team in a matrix environment across multiple time zones Expertise in computer applications such as Veeva, Spotfire, SHINY Expertise in MS Office (Word, Excel, PowerPoint, MS Teams) Soft Skills: Analytical and problem-solving skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Roles and Responsibilities Ensure compliance with regulatory requirements from USFDA, GMP, WHO, and other relevant authorities. Conduct internal audits to identify areas of improvement and implement corrective actions. Develop and maintain relationships with regulatory agencies to ensure smooth operations. Provide guidance on Good Manufacturing Practices (GMP) and Current Good Manufacturing Practice (cGMP) guidelines. Collaborate with cross-functional teams to resolve regulatory issues. Desired Candidate Profile 5-10 years of experience in Regulatory Affairs or related field. Strong knowledge of Allopathy or homeopathy regulations and guidelines. Proven track record of handling regulatory audits successfully. homoeopathy

Administer and manage DB2 databases with Linux,Unix,windowes, ensuring high availability, performance, and security. - Install, configure, and maintain DB2 databases in production and non-production environments. - Perform database backups, recovery, and disaster recovery processes. - Monitor database performance and optimize queries for better performance. - Troubleshoot and resolve database issues, ensuring minimal downtime. - Implement security measures such as access control, encryption, and auditing. - Work with development teams to design and optimize database schemas, indexes, and queries. - Conduct regular database health checks and tuning. - Apply patches, updates, and upgrades to DB2 systems. - Provide on-call support and ensure adherence to SLAs. - Prepare and maintain database documentation, including architecture, design, and best practices. - Ensure compliance with regulatory requirements (e.g., GMP, cGMP, etc.) in database management

Dear Candidate, WE ARE HIRING Department: - Production- DS Designation: - Dy Manager / Manager Qualification: - Preferably Post Graduation in Science Experience: - 15+ Years Age: - Between 35- 40Years Mandatory: - Should come in all shifts, including Night shifts Role: Shift-in-charge for entire DS floor Job Description: > Strong Functional knowledge of DS Biologics (Chromatography and related purification experience protein/ Insulin handling experience preferable). Capable of handling large teams as we have around 45 members in each shift, around 50% of contractual staff. Strong administration / team management capabilities to streamline GMP across the floor. Monitoring the efficiency of employee performance on the job. > Coordinating with other departments to ensure that production runs smoothly Ensuring that all safety regulations are followed in the production area. Managing all aspects of production, including hiring workers, ordering supplies, maintaining production schedules, and overseeing equipment maintenance. Reviewing production schedules and work orders to ensure that production goals are being met in handling QMS activities. for more details please reach out Venkat -9381915043 or please share your CV to venkateswara.k@talent21.in

Role & responsibilities Job Title : Executive / Sr. Executive Blending Department (Aroma Chemicals) Department : Production / Blending Location : Daund Reports To : Production Manager Job Summary : Responsible for managing the blending operations of aroma chemicals in accordance with batch production schedules, ensuring product quality, safety, and compliance with SOPs and regulatory standards. Key Responsibilities : Batch Preparation & Execution : Execute daily blending operations as per the batch manufacturing record (BMR). Accurately weigh and mix raw materials and aroma chemicals. Ensure proper sequencing to avoid cross-contamination. Quality & Compliance : Coordinate with QC/QA for in-process and final product testing. Maintain strict adherence to GMP, ISO, and EHS standards. Maintain batch traceability and ensure proper documentation. Inventory & Material Handling : Monitor and manage raw material and packing material availability. Coordinate with the warehouse for material issuance and returns. Maintain accurate records of material usage and wastage. Equipment Handling & Maintenance : Operate and monitor blending equipment such as mixers, tanks, agitators, etc. Ensure routine equipment cleaning and preventive maintenance as per SOPs. Report any equipment faults or malfunctions promptly. Documentation & Reporting : Prepare daily production reports and logbooks. Update SAP/ERP entries for batch progress and material consumption. Assist in audits and provide relevant documentation when required. Team Coordination : Guide and supervise blending assistants/operators. Ensure shift handovers are smooth and information is well communicated. Participate in continuous improvement initiatives. Desired Candidate Profile : Education : B.Sc. / M.Sc. in Chemistry, or Diploma / B.Tech in Chemical Engineering. Experience : 2 to 6 years in the blending department of an aroma chemicals, fragrance, or specialty chemicals company. Skills : Sound understanding of chemical handling and blending processes. Knowledge of GMP, ISO standards, and safety protocols. Proficient in SAP/ERP and production reporting. Good communication and team coordination skills.

We are hiring for a Public listed BSE / NSE - Pharma - API / Crop Protection / Animal Health Intermediates Mfg CDMO / CRAM Company. Role : Team Leader - ADL Title : Sr. Scientist R&D Centre Level : Deputy Manager CTC : Ceiling Rs 15 Lpa Experience: Minimum 14 years to Max 18 years Those working at R&D Centres of Crop Sciences / API / Specialty Chemicals are only eligible. Formulations / Vaccines / Bio labs are not eligible. Formulations Qualification : Full Time M.Sc in Organic Chemistry / Analytical Chemistry only. Those in other specialisation of Chemistry are not eligible. Those with Correspondence Masters degree won't qualify. Location: Pune Saturdays: 2nd / 4th Not working Local Company Transport on the major Trunk Road available. Those working in QC Labs not eligible. Those working in Foods Lab not eligible. Those working in Testing Laboratories should not apply. Role: To follow Good laboratory Practices. To follow the procedures mentioned in SOP's and General test Procedures To ensure availability of respective working standards/samples for method validation and method transfer activity To monitor periodic calibration of instruments as per the schedule To follow all safety standards while working To fulfil the requirement of RA department for different filings To review method validation data & preparation of respective protocol reports To ensure documentation of analytical activities as per Co. policy To provide complete support for internal & external Audits at Pune location To develop suitable analytical methods to support cross functional teams To prepare and review method validation protocols, data and reports

Role & responsibilities 1. Production Planning and Scheduling 2. Compliance and Documentation 3. Supervision of Manufacturing Processes 4. Personnel Management and Training 5. Quality and In-Process Control 7. Process Optimization and Yield Improvement 8. Regulatory and Customer Audits Preferred candidate profile Education: B.Pharm / M.Pharm / B.Sc with strong domain knowledge in OSD manufacturing. Experience: 15+ years in pharmaceutical production, with at least 5 years in a managerial role overseeing OSD manufacturing. Regulatory Exposure: Hands-on experience in facing WHO-GMP, and other inspections. Skills: Leadership, decision-making, analytical thinking, team management, and strong knowledge of GMP and QMS.

Department: Pharma Standard - AD Required Qualification & Experience: M.Sc. in any Life science(s)/Analytical/M-Pharmacy, with 0 - 5 Years of experience in the field of pharmaceutical industry/CRO setup. For Preparative: Experience on instruments like Preparative HPLC and SFC Expertise in Purification of peptides, impurity isolation. For Analytical: Expertise Analytical Method Development of peptides and oligoes. Regular sample analysis for supporting to synthesis team. Handling experience on DAC column packer and media packing will be advantageous. Department: Pharma Standard - Quality Control Required Qualification & Experience: M.Sc. in any Life science(s)/Analytical/M-Pharmacy, with 0 - 5 Years of experience in the field of pharmaceutical industry/CRO setup. Theoretical knowledge and hands-on experience on instruments like Shimadzu HPLC with Lab solution software, Agilent HPLC, Balance, pH meter, TGA instrument, FTIR. CGMP,GMP, experience on LCMS is preferrable. Knowledge on Data Integrity, GDP, QMS. Department: Pharma Standard - Inventory Required Qualification & Experience: M.Sc. in any Life science(s)/Analytical/M-Pharmacy, with 0 - 5 Years of experience in the field of pharmaceutical industry/CRO setup. Management of Inventory items, handling, weighing, dispatching of inventory materials. Hands-on experience on semi-microbalance, microbalance. Maintaining Real time stock updation of the inventory list in excel or SAP system and updating the stock quantities to the relevant stakeholders, whenever required. Basic understanding on Data Integrity, GDP and QMS Please bring your Updated CV along with last 3 Months Payslips, Recent Increment Letter, Aadhar Card/PAN Card: Date : Saturday, 10 May 2025 Time: 09:00 AM to 4:00 PM Walk-in Interview Location: Daicel Chiral Technologies (India) Pvt Ltd Genme Valley, IKP Knowledge Park, Survey No. 542/2, Koltur Village, Shamirpet Mandal, Medchal-Malkajgiri District, Hyderabad-500101 Note: Candidates who are unable to walk-In, May send their resume to hr@chiral.daice.com or whatsApp to 9000066897

Department: Pharma Standard - AD Required Qualification & Experience: M.Sc. in any Life science(s)/Analytical/M-Pharmacy, with 0 - 5 Years of experience in the field of pharmaceutical industry/CRO setup. For Preparative: Experience on instruments like Preparative HPLC and SFC Expertise in Purification of peptides, impurity isolation. For Analytical: Expertise Analytical Method Development of peptides and oligoes. Regular sample analysis for supporting to synthesis team. Handling experience on DAC column packer and media packing will be advantageous. ************************************************************************************************** Department: Pharma Standard - Quality Control Required Qualification & Experience: M.Sc. in any Life science(s)/Analytical/M-Pharmacy, with 0 - 5 Years of experience in the field of pharmaceutical industry/CRO setup. Theoretical knowledge and hands-on experience on instruments like Shimadzu HPLC with Lab solution software, Agilent HPLC, Balance, pH meter, TGA instrument, FTIR. CGMP,GMP, experience on LCMS is preferrable. Knowledge on Data Integrity, GDP, QMS. ************************************************************************************************** Department: Pharma Standard - Inventory Required Qualification & Experience: M.Sc. in any Life science(s)/Analytical/M-Pharmacy, with 0 - 5 Years of experience in the field of pharmaceutical industry/CRO setup. Management of Inventory items, handling, weighing, dispatching of inventory materials. Hands-on experience on semi-microbalance, microbalance. Maintaining Real time stock updation of the inventory list in excel or SAP system and updating the stock quantities to the relevant stakeholders, whenever required. Basic understanding on Data Integrity, GDP and QMS Please bring your Updated CV along with last 3 Months Payslips, Recent Increment Letter, Aadhar Card/PAN Card: Date : Saturday, 10 May 2025 Time: 09:00 AM to 4:00 PM Walk-in Interview Location: Daicel Chiral Technologies (India) Pvt Ltd Genme Valley, IKP Knowledge Park, Survey No. 542/2, Koltur Village, Shamirpet Mandal, Medchal-Malkajgiri District, Hyderabad-500101 Note: Candidates who are unable to walk-In, May send their resume to hr@chiral.daice.com or whatsApp to 9000066897

Key Responsibilities: Operate, monitor, and maintain Lyophilizers, HVAC systems, chillers, and AHUs to ensure efficient functioning. Perform routine and emergency maintenance tasks, ensuring minimal downtime and optimal performance of equipment. Maintain accurate operational records and detailed maintenance logs for all equipment. Ensure adherence to cGMP (current Good Manufacturing Practices) and cleanroom standards in daily operations. Follow Quality Management System (QMS) protocols, including SOPs (Standard Operating Procedures), change control, and Corrective and Preventive Actions (CAPA). Troubleshoot equipment issues and implement effective solutions to prevent recurrence. Conduct equipment qualification and requalification processes to ensure compliance with regulatory requirements. Collaborate closely with cross-functional teams and leadership to meet production and operational goals. Job Location: Bus transportation facility available from Ahmedabad, Kalol & Kadi. Education Qualification: I.T.I Fitter

Carry out the manufacturing operations according to the BPCR provided by QA department Perform the Operations in accordance to the established SOPs and cGMP. To maintain for Good documentation practice .To execute Production planning schedule. Required Candidate profile < Qualification : B.sc /M.sc(Chemistry)/B. Pharmacy/B. Tech ( Chem engg) - Any chemistry Background. < Having Pharma Experience of 2- 8 Years of experience. Perks and benefits Free Bus , Canteen, Pf

Manage the technology transfer process for established products, ensuring robust and compliant manufacturing processes e.g. implementation of new API sources. Write, review, and maintain regulatory response documents, justification reports, and risk assessments related to technology transfer activities. Oversee the preparation and review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for smooth transfer and manufacturing. Review process validation protocols and reports. Coordinate with R&D, production, quality assurance, and regulatory teams to ensure alignment on project deliverables and timelines. Troubleshoot and optimize manufacturing processes addressing deviations and improving efficiency. Conduct technical risk assessments to identify and mitigate potential issues during and post-transfer. Maintain comprehensive documentation to ensure compliance with regulatory standards (e.g., FDA, EMA, cGMP) and internal quality guidelines. Stay updated on regulatory trends and industry standards to continuously improve documentation practices and technology transfer methodologies.