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15.0 - 19.0 years

0 Lacs

karnataka

On-site

The role of General Manager, Veterinary Sciences at Syngene International Ltd. in Bangalore is a highly strategic position responsible for leading the BBRCs in vivo research operations. As the Head of Veterinary Sciences, you will oversee a 50,000 sq. ft. AAALAC-accredited facility supporting various therapeutic and functional areas. Reporting to BMS Veterinary Sciences leadership and the Head of Site Operations, you will play a crucial role in the BBRC Operations Leadership Team. Your main responsibilities will include ensuring high-quality support for in vivo pharmacology, DMPK, toxicology, and translational research within the Veterinary Sciences BBRC function. You will collaborate with global stakeholders to align strategies across R&D sites and drive long-term strategies to develop capabilities and capacity in support of BMS drug discovery portfolio. As a leader, you will be responsible for coaching and developing a multidisciplinary team to meet departmental objectives while fostering a culture of excellence, collaboration, accountability, and continuous learning. Oversight of local aspects of veterinary care, animal welfare, and vivarium operations to ensure compliance with international regulations and BMS standards will also be part of your role. Your qualifications should include a PhD in Veterinary Science (a plus), board certification in Laboratory Animal Medicine, eligibility for veterinary licensure in India, and at least 15 years of experience in laboratory animal medicine with leadership roles in pharmaceutical or research settings. Additionally, you should have expertise across multiple species used in pharmaceutical research, strategic acumen in managing vivarium and veterinary functions, strong interpersonal and communication skills, and the ability to manage multiple projects with resilience and emotional intelligence. Preferred attributes for this role include operational leadership of multi-site or global veterinary functions, scientific innovation in developing in vivo disease models, and a passion for ethical research, leadership, and high-performing team development. Syngene International Ltd. is an equal opportunity employer committed to fostering a diverse and inclusive workplace.,

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3.0 - 7.0 years

0 Lacs

navi mumbai, maharashtra

On-site

As a Quality Analyst I at Teva Pharmaceuticals, you will be responsible for auditing each BA/BE study to ensure that facilities, personnel, equipment, instruments, protocols, methods, practice, records, and controls comply with relevant GCP/GLP guidelines, protocols, and SOPs. Your day will involve reviewing SOPs, forms, logbooks of departments, providing feedback, reviewing change control and deviations, and preparing audit reports in accordance with guidelines and regulatory inspections. You will also conduct in-process study audits to ensure compliance with GCP/GLP, protocols, SOPs, and regulatory requirements. Additionally, you will audit raw data, validation reports, bioanalytical reports, PK and statistical outputs, bio-summary tables, eCTD compilations, and collaborate with Biostatisticians and medical writers for finalization of reports. Furthermore, you will review audit trails on LC-MS/MS instruments, conduct area-specific audits, system audits, vendor audits, calibration records, and issue documents such as SOPs, protocols, and logbooks. Your role will involve ensuring compliance and adherence to quality standards in bioanalytical processes. To qualify for this role, you should have a B.Pharm, M.Pharm, or M.Sc degree with 3-6 years of experience in Bioanalytical Quality Assurance for a BA/BE Study. Join us on our mission to make good health more affordable and accessible, impacting millions of lives worldwide. Apply now to be a part of Teva Pharmaceuticals and contribute to our commitment to Equal Employment Opportunity.,

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2.0 - 3.0 years

7 - 11 Lacs

Thane

Work from Office

Job Title: Cyber Security Specialist Location: Ambernath, India Job Type: Full-Time Reporting : CISO, Global IT Governance About Polypeptide Group: PolyPeptide Group AG and its consolidated subsidiaries ( PolyPeptide ) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide s shares (SIX: PPGN) are listed on SIX Swiss Exchange. Position Overview: We are seeking a diligent and detail-oriented Cybersecurity specialist to join our cybersecurity team. This role is focused on executing vulnerability scans, analyzing results, and coordinating mitigation efforts to reduce risk across the organization. The candidate should be hands-on with tools like NMAP/ Zenmap and able to generate insightful visualizations and reports using Power BI . As the rest of the team is located in Europe (Sweden), flexibility in working times, and to be self-driven and efficient is highly rated. Key Responsibilities: Conduct regular vulnerability assessments using tools such as NMAP/ Zenmap to identify security weaknesses in systems and applications. Analyze scan results, assess risk severity, and escalate critical findings to appropriate stakeholders for timely action. Collaborate with IT and application teams to ensure effective remediation of identified vulnerabilities and verify implemented fixes. Track and document remediation progress, ensuring closure of findings and proper risk mitigation. Develop and maintain reports and dashboards (preferably using Power BI) to monitor vulnerability trends, risk exposure, and key performance indicators (KPIs). Continuously improve and standardize vulnerability management processes and workflows, ensuring alignment with industry standards. Stay updated on the latest security vulnerabilities, exploits, and remediation techniques, and apply threat intelligence to prioritize risks. Work in coordination with the Security Operations Center (SOC) to address vulnerabilities associated with active threats. Participate in patch management and configuration compliance cycles, following security benchmarks such as CIS, NIST, or ISO 27001. Maintain an accurate and up-to-date asset inventory, ensuring comprehensive coverage in scanning and remediation activities. Contribute to the development of security awareness materials, particularly focused on vulnerability risks and secure practices. Create and maintain relevant documentation, SOPs, and playbooks for vulnerability scanning, triage, and response procedures. Support third-party risk assessments by evaluating external vendors vulnerability exposure and security posture. Participate in red/blue team exercises and tabletop simulations to evaluate and improve vulnerability response readiness. Assist during audits and assessments, with occasional travel as required. Be available to contribute during U.S. operational hours at regular intervals , supporting cross-time-zone collaboration and incident response as needed. Qualifications & Requirements: Bachelor s degree in Cybersecurity, Computer Science, or related field (or equivalent hands-on experience). 2 3+ years of experience in vulnerability management, security operations, or related fields. Strong hands-on experience with NMAP/ Zenmap for scanning and analysis. Familiarity with vulnerability scoring systems like CVSS . Working knowledge of vulnerability management lifecycle and remediation workflows. Experience generating actionable reports and insights; Power BI experience is a plus . Strong analytical and communication skills. Strong skills in writing and speaking English Preferred Qualifications: Certifications such as CompTIA Security+, CEH, or equivalent are desirable. Experience with additional scanning tools (e.g., Nessus, Qualys) is a plus. Familiarity with security standards and frameworks (e.g., ISO 27001, NIST); NIS2 knowledge is a plus . Why Join Us at Polypeptide Group: Polypeptide Group offers an exciting opportunity to work at the forefront of peptide-based therapeutics, a rapidly growing and innovative segment of the pharmaceutical industry. As a key member of our Global IT Cyber Security and IT Compliance, you will have the opportunity to contribute to a company that is dedicated to the success of its clients and the advancement of peptide science. Join us and be part of a global organization that is shaping the future of life-saving therapies. ",

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3.0 - 5.0 years

2 - 5 Lacs

Bhiwandi

Work from Office

The Roles Responsibilities are: To arrange laboratory as per Good Laboratory practice (GLP). To prepare Standard operating procedures. To prepare Standard testing procedures To prepare Instrument Operating procedures. To calibrate all the instruments at specified regular intervals. Method development. To prepare and maintain QA/QC documents and registers. To maintain standard records and documents as per FAMI-QS. Inspect, test, or measure materials or products being produced Report inspection and test data. To carry out any work given by QC/Lab Incharge. To carry out the analysis work and report any abnormality to Seniors To do the analysis of RM / In-process / FP by chemicals instrumental methods of analysis. To prepare SOP for QC Instruments, and STP for RM / FP. To do the calibration of Instruments as and when required. Mandatory Skills: B.Sc or M.Sc with Chemistry. Should have working experience of 3-5 yrs. Knowledge of Wet Chemical analysis. Knowledge of Instrumental Analysis. Knowledge of Documentation SOPs and STPs. Knowledge of preparation of COA. To carry out daily calibration of instruments Desired Skills Well Versed with Titrimetric analysis. Well Versed with the handling of UV, GC, and HPLC. Should be able to prepare SOPs, STPs of RM, and FP when required. Should be able to prepare COA of FP when needed. To do daily calibration of Instruments like balance, PH meter, periodic calibration of GC, HPLC, UV. Designation: QC Executive / QC Officer. Job Location: Bhiwandi. Experience: Candidate with 3 to 5 years of experience. Qualification: B.Sc. or M.Sc. in Chemistry Qualifications Experience can be relaxed in the case of exceptionally talented candidates with the approval of Management

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2.0 - 4.0 years

3 - 8 Lacs

Bengaluru

Work from Office

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Under the guidance of Manager-Instrumentation / R&D , responsible for installation, maintenance and calibration of all the instruments in Apotex Research Pvt Ltd as per GMP/GLP requirements. Also responsible to generate and maintain laboratory equipment documentation. Job Responsibilities Conducts duties following established Apotex Research Pvt. Ltd., Standard Operating Procedures and in a consistent manner consistent with current regulatory (GMP, DCGI- CDSCO,TPD, USFDA, TGA, ICH, GLP, EMEA) guidelines / established practices / expectations. Perform maintenance and calibration of analytical instruments like HPLCs, GCs, pipettes, balances, etc and maintain instruments in good working order. Monitor and support during instruments installations and qualifications. Prepare and revise instrument related SOPs. Assists and involve in preparation and execution of documents for software validations. Maintain/Oversee all the instrument related qualification files, software validation reports, routine calibration records their scheduled archiving. Arrange vendor engineers for maintenance/calibration and maintain necessary AMC contracts with vendors. Update and maintain the Master list of instruments and calibration schedules. Monitor freezer/environmental monitoring system and respond to the alarms. Documents all the work and results of all assignments as required. Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor or management. Ensures that all work is performed in compliance with all pertinent SOP, GLPs, GALP and Safe Work Practices. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Minimum BE / B.Tech / M.Sc. Instrumentation. 2 to 4 years of experience in Instrumentation of AR&D, Bioanlaytical lab, QC labs. Experience with analytical laboratory equipment like HPLC, LC/MS/MS, GCs etc. for trouble shooting, repairs, calibraitons, qualifications, etc. Fundamental understanding of concepts of GMP, GLP, GCP, 21 CFR Part 11guidelines. Computer skills in laboratory data acquisition software(s), spreadsheets and word processing. At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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1.0 - 5.0 years

3 - 7 Lacs

Kolkata, Mumbai, New Delhi

Work from Office

Amneal Pharmaceuticals is looking for Officer, Quality Control to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes

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2.0 - 7.0 years

1 - 6 Lacs

Amreli

Work from Office

Role & responsibilities Experience in Validation. Qualification of analytical instrument. Review & approve the standard operating procedures. Review and approve the Specification and Standard testing procedures. Review and approve the Calibration record. Review and approve the working standard qualification record. Review and approve the volumetric solution preparation and standardization record. Perform the gap analysis and address the observation with effective CAPA. Handling OOS, OOT and OOC. Preparation of Audit compliance report and effective implementation of same. Handle the training in the QC Dept. To ensure GLP in QC Lab. To ensure GMP in QC Lab. To ensure the Safety in QC Lab.

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20.0 - 30.0 years

500 - 1000 Lacs

Hyderabad

Work from Office

Conduct final inspection and testing of finished products to ensure compliance with quality standards and customer specifications. Hands-on experience in testing of Finished products Instruments must be handled like HPLC, GC, KF, IR, DT, and Dissolution. Hands-on experience like software like Empower and LIMS. Qualification M.SC/B.Pharma 3 to 6 years Additional Information

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2.0 - 3.0 years

4 - 6 Lacs

Hyderabad, Pune, Bengaluru

Work from Office

GxP, GLP, regulatory environments Support Analyst Role: Support Analyst / Application Administrator We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applications supporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system functionality. Maintain and review system SOPs, user manuals, and ensure audit readiness. Liaise with IT and vendors to resolve technical escalations and system configurations. Must-Have Qualifications: 2-3 years of relevant support or application administration experience Strong skills in MS Excel, MS Word, and business/technical applications Understanding of GxP, GLP, regulatory environments, and computer validation principles Bachelor's degree (or equivalent experience) Preferred Skills: Familiarity with NG/Pristima, Tox Reporting tools Experience supporting lab-based systems or instruments Knowledge in small project management and release control

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2.0 - 3.0 years

4 - 6 Lacs

Ankleshwar

Work from Office

B.Sc/M.Sc. with 1–4 years in QA (API preferred). Strong in GMP, documentation, audits, and QMS. Detail-oriented, compliant, and reliable. Ready to ensure quality excellence in a world-class pharma environment. Required Candidate profile B.Sc/M.Sc. with 1–4 years’ QA experience in API. Skilled in GMP, documentation, audits, and QMS. Detail-oriented, disciplined, and committed to quality compliance. Perks and benefits GMP GLP plant |Growth |Safety |Compliance |Perks

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2.0 - 6.0 years

2 - 5 Lacs

Ranipet

Work from Office

Role & responsibilities Ensuring the cleanliness and housekeeping activities in the laboratory. Ensuring the laboratory safety. Calibration of analytical instruments like High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC). Analysis of raw material, in-process, finished product and stability samples using HPLC & GC. Analysis of vendor samples as part of vendor qualification. Analysis of cleaning samples using UV & HPLC. Analytical method validation, method transfer and verification analysis as per protocol. Analytical column performance and maintenance. Temperature and humidity daily check in HPLC room. Preferred candidate profile Analytical Chemistry Documentation skills GMP, cGMP/ GLP Skills Interpersonal skills 5S skills( Sort, Straighten, Shine, Standardize& Sustain)

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3.0 - 7.0 years

0 Lacs

maharashtra

On-site

As a Quality Assurance Specialist in the chemical or pharmaceutical industry, you will be responsible for conducting chemical and physical testing on raw materials, in-process samples, and finished products. Your role will involve analyzing and interpreting test results to ensure compliance with quality standards and regulatory requirements. It is essential to document and report testing procedures and results accurately to maintain quality control. In this position, you will be expected to identify and troubleshoot any quality issues efficiently. It is crucial to maintain and calibrate laboratory instruments and equipment, as well as develop and implement quality control processes and procedures. Collaboration with production, warehouse, procurement, sales, and planning teams is necessary to enhance product quality. As part of your responsibilities, staying updated with industry standards and advancements in quality assurance practices is vital. Your experience in a quality assurance role within the chemical or pharmaceutical industry will be beneficial, along with a strong knowledge of analytical chemistry techniques and instrumentation. Familiarity with regulatory requirements and quality standards such as GLP, GMP, etc., is required. You should possess excellent attention to detail and problem-solving skills, along with the ability to work both independently and as part of a team. Strong written and verbal communication skills are essential for effectively documenting procedures and communicating with various stakeholders. A proactive attitude towards delegation and taking on new challenges independently is expected, coupled with a hunger for knowledge and a collaborative approach to teamwork. This is a full-time role that requires a Master's degree and a minimum of 3 years of experience in quality assurance. The position offers benefits such as Provident Fund, and the ideal candidate will be a team player with leadership qualities, committed to making a positive impact in quality assurance practices.,

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2.0 - 6.0 years

0 Lacs

saharanpur, uttar pradesh

On-site

As a Quality Control (QC) Analyst at Jubilant Generics, you will be responsible for various tasks related to ensuring the quality and compliance of pharmaceutical products. Your role will involve sampling and analyzing packing materials and raw materials, conducting in-process quality control, and preparing specifications and test procedures. Additionally, you will be responsible for maintaining artwork and shade cards, as well as calibrating and validating instruments and equipment. Your attention to detail will be crucial in recording analytical data accurately and preparing records of analysis for both raw materials and finished products, including stability samples. In this role, it is essential to uphold cGMP (current Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance at all times. You will also be involved in investigating deviations, incidents, and out-of-specification results, ensuring that corrective actions are implemented promptly. Furthermore, maintaining a clean and organized work environment is important, and you will play a key role in ensuring good housekeeping practices in the laboratory. Your contribution to these quality control processes will ultimately support Jubilant Pharma's commitment to delivering high-quality pharmaceutical products to customers worldwide. For more information about Jubilant Pharma and its operations, please visit www.jubilantpharma.com.,

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3.0 - 6.0 years

3 - 5 Lacs

Dholka, Ahmedabad

Work from Office

Role & responsibilities: 1. Act as Study Director for various Pre-Clinical studies as per guidelines 2. Conduct, schedule & report toxicological studies for various products in pre-clinical studies 3. Conduct Pharmacological evaluation of various pharmaceutical products 4. Preparation of SOP & documentation as per guidelines 5. Ensuring facility readiness as per regulatory guidelines & audits Preferred candidate profile: Local candidates

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3.0 - 7.0 years

5 - 9 Lacs

Ahmedabad

Work from Office

Maintain media stock and reconcile records of media used in analysis. Perform water sampling and analysis following defined SOPs/protocols and ensure proper documentation. Report and log OOS (Out of Specification), OOT (Out of Trend), and EM (Environmental Monitoring) excursions. Conduct environmental monitoring of the laboratory. Perform analytical validation, culture maintenance, and growth promotion testing (GPT) of media; record observations and generate reports. Carry out microbiology laboratory tests such as Bioburden Analysis, MLT (Microbial Limit Test), Sterility Testing, BET (Bacterial Endotoxin Test), etc., in compliance with approved procedures. Skills and Proficiency: Microbiology Instrumentation Handling Expert Good Laboratory Practices (GLP) & Documentation Accuracy Practitioner Data Integrity & Documentation Practitioner Regulatory Compliance Practitioner SOP Preparation & Revision Practitioner BET & Sterility testing expertise and evaluation skills Expert Interpretation of Resulting Data Trend Practitioner Laboratory Instrument qualification, Calibration & Maintenance Practitioner Quality Control & Compliance Practitioner QMS Documentation (OOS, OOT, Deviation & Incident) Beginner CAPA, Deviation, and Change Control Management Beginner

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4.0 - 10.0 years

6 - 12 Lacs

Ahmedabad

Work from Office

Analyst with having the knowledge of Instrument HPLC, UV, FTIR, GC ,Polarimeter , KF, Auto titrator e.t.c. Responsible for sampling, testing and release of Raw material, packing material and miscellaneous material samples and maintain reserve sample as per SOP. Responsible for review of instruments logbooks, raw data of raw materials, packing materials, miscellaneous materials, in-process, finished products and water analysis. Analysis related to qualification of Instrument/Equipment and Standards Qualification of Standards and Instruments Knowledge and Skill on Sophisticated instruments like UV, HPLC, GC, UPLC, FTIR, Polarimeter and KFtitrator. Knowledge of Chemical analysis. Knowledge of LIMS/QMS Knowledge of current pharmaceuticals guidelines (eg. ICH, cGMP etc.) Troubleshooting and decision skills for analytical problems. Responsible to perform activities with respective TNI . To ensure the timeline for initiation and completion of testing. Responsible to maintain quality standards that apply to product Analysis, ensuring proper implementation. To maintain the cleaning in quality control department Skills and Proficiency: Analytical Instrumentation Handling Expert Particulate Matter Testing Practitioner Good Laboratory Practices (GLP) & Documentation Accuracy Practitioner Data Integrity & Documentation Practitioner Regulatory Compliance Practitioner SOP Preparation & Revision Practitioner Analytical testing expertise and evaluation skills Expert Handling of Analytical Instruments and Interpretation of Resulting Data Practitioner Laboratory Instrument qualification, Calibration & Maintenance Practitioner Quality Control & Compliance Practitioner LIMS Operation & Data Management Practitioner QMS Documentation (OOS, OOT, Deviation & Incident) Beginner CAPA, Deviation, and Change Control Management Beginner

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4.0 - 10.0 years

6 - 12 Lacs

Ahmedabad

Work from Office

Analyst with having the knowledge of Instrument HPLC, UV, FTIR, GC ,Polarimeter , KF, Autotitratior e.t.c. Responsible for sampling, testing and release of Raw material, packing material and miscellaneous material samples and maintain reserve sample as per SOP. Responsible for review of instruments logbooks, raw data of raw materials, packing materials, miscellaneous materials, in-process, finished products and water analysis. Knowledge of Chemical analysis. Knowledge of LIMS/QMS Skills and Proficiency: Analytical Instrumentation Handling Expert Particulate Matter Testing Practitioner Good Laboratory Practices (GLP) & Documentation Accuracy Practitioner Data Integrity & Documentation Practitioner Regulatory Compliance Practitioner SOP Preparation & Revision Practitioner Analytical testing expertise and evaluation skills Expert Handling of Analytical Instruments and Interpretation of Resulting Data Practitioner Laboratory Instrument qualification, Calibration & Maintenance Practitioner Quality Control & Compliance Practitioner LIMS Operation & Data Management Practitioner QMS Documentation (OOS, OOT, Deviation & Incident) Beginner CAPA, Deviation, and Change Control Management Beginner

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1.0 - 5.0 years

3 - 7 Lacs

Ahmedabad

Work from Office

Analyst with having the knowledge of Instrument HPLC, UV, FTIR, GC, Polarimeter , KF, Auto titrator e.t.c. Responsible for QCC-QMS Section regarding the test procedure, OOS, OOAL, Deviation, Change Control Note, Incident, Investigation Report Preparation e.t.c. Responsible for review of instruments logbooks, raw data of raw materials, packing materials, miscellaneous materials, in-process, finished products and water analysis. Responsible for QCC-QMS Section regarding the test procedure, OOS, OOAL, Deviation, Change Control Note, Incident , Investigation Report Preparation e.t.c. Skills and Proficiency: Analytical Instrumentation Handling Practitioner Good Laboratory Practices (GLP) & Documentation Accuracy Practitioner Data Integrity & Documentation Practitioner Regulatory Compliance Practitioner SOP Preparation & Revision Practitioner Handling of Analytical Instruments and Interpretation of Resulting Data Practitioner Quality Control & Compliance Practitioner LIMS Operation & Data Management Practitioner QMS Documentation (OOS, OOT, Deviation & Incident) Beginner CAPA, Deviation, and Change Control Management Beginner

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10.0 - 12.0 years

10 - 12 Lacs

Hyderabad

Work from Office

Job Title : Assistant Manager Or Deputy Manager Job Location : Hyderabad Department : QA Reports to : HOD Job Objective : To perform the QA activities in view of system upgradation and improvement in the existing procedures. Job Role: 1. Execution & co-ordination for investigations, Identification of root cause along with assignment of adequate CAPAs for Returned material, Incidents, Deviation, OOS, OOT, complaints & other quality events. 2. Logging, Review & Closing of the change controls and CAPAs along with implementation of CAPA and its effectiveness verification as applicable. 3. Responsible as site representative during Regulatory Audits and customer inspections to co-ordinate with the Inspectors /Auditors. 4. Preparation & review of quality risk assessment reports of products & general systems 5. Conduct on the Job Training and cGMP trainings. 6. Implement documentation system to develop, maintain, distribute and control of all Quality Control, Quality Assurance, Production, Maintenance and Warehouse records. 7. Planning & execution of internal quality audits and perform vendor audits for the KSMs and packaging materials for vendor qualification. 8. Co-ordination with the customer for compliance and day to day issues. 9. Quality agreements review and preparation. Job Qualification: Masters in Chemistry (Any specialization) Job Experience: 10 to 12 years Desired attributes: Technical / Functional: Should have exhaustive knowledge on the drafting skills (E.g. Investigations, Responses & compliance). Should have sound command on the English with speaking and Writing. Sound knowledge of the production operations, QC analytical techniques & facility and maintenance functions. Behavioral: Team management, Leadership, Project management, Proactive, Time management and Critical thinker.

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2.0 - 6.0 years

0 Lacs

kolkata, west bengal

On-site

You will be responsible for providing drug metabolism and pharmacokinetic support for discovery programs. Your main duties will include monitoring Pharmacokinetics studies, supporting bioanalysis, and offering pre-clinical ADME lead optimization support to small molecule Drug Discovery programs across various therapeutic areas. You will be working as a DMPK subject matter lead in multidisciplinary/cross-functional teams to understand the Chemical Structure ADME relationships and design appropriate strategies to enhance the Drug like Properties of the New Chemical Entities. To be successful in this role, you should have 2-5 years of experience in GLP with either an M.Sc. or Ph.D. degree. You should possess expertise in Bioanalysis using LC-MS/MS in both GLP and non-GLP environments. Additionally, you should be capable of leading projects as a DMPK representative, quantifying small molecules using LC-MS/MS, and conducting metabolite identification work on High-resolution mass spectrometry. Qualifications required for this position include an M. Pharm (Pharmacology / Pharmaceutical Analysis) or an M.Sc. (Biochemistry / Pharmaceutical Chemistry).,

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3.0 - 8.0 years

3 - 7 Lacs

Ahmedabad

Work from Office

We are conducting Walk-in Interview at Indore for our OSD manufacturing Facility based out of our Ahmedabad (SEZ-II), please find the below details. Date : 27th May 2025 (Sunday) Interview Location: Ahmedabad Timings: 9:00 am 5:00 pm Interview Venue: PTC-Sigma Block No. 2, 3, 4, 5, Sigma Commerce Zone,Nr Iskon Mandir BRTS Bus Stand, Ambli Bopal Road, Ahmedabad – 380015 ? Job Location: Ahmedabad Education Qualification: ITI/Diploma/BSC/ /B.Pharma Departments are as follows : Production- OSD : Plant Operator/ Technical Assistant : ITI / Diploma having 3 - 8 years of experience in operating machines like Granulation (ACG, Glatt, Tapasya, GEA), Fitzpatrick Roll Compactor, Compression machines (Fette), Wurster Coater (ACG, Glatt, Anish), imprinting, Visual Inspection. Perform line clearance, operation and cleaning of equipment / instrument / auxiliary items Executive/ Sr Executive: B. Pharma with 3 - 8 years of experience in Tablet/ Capsule department with experience in Granulation, Compression, Coating, Inspection . Responsible to plan for the manufacturing of batches in coordination with PPMC. To monitor line clearance, cleaning of equipment, instrument, auxiliary items. To carry out qualification activities. To initiate QMS activities (Change control, deviation, CAPA, investigation) and E-BMR. To handle manpower and allocate daily activities.. Engineering: Technician : Diploma / ITI with 3- 8 years of experience in plant maintenance & Process Equipment (Electrical/ Instrumentation) and Instrumentation . Candidates should have experience in Plant maintenance, preventive maintenance and breakdown maintenance of OSD plant equipment. Troubleshooting of mechanical and electrical equipment . Instrument and calibration of OSD plant equipment. They should have knowledge and experience in instruments sensors, PLC, HML, SCADA, and experience in calibration activities. Quality Assurance (Qualification) Assistant Manager / Deputy Manager / Associate Manager: B.Pharm with 10-20 years QA & MFG – Qualification. Candidates should have experience in Qualification, Validation. They would have to prepare, execute and review of equipment/ instrument/ system /utility /area qualification program. Review of data backup activity, data restoration and its compliance. QMS documentation exposure is required. completion of CAPAs and to perform change control/CAPA effectiveness. Associate Manager: CSV B.Pharm with 15-20 years with experience in Issuance and retrieval of documents. Candidate should have experience in Review of various Qualification and CSV Documents. Review of system audit trail, system security user privileges and ensure the compliance. Review of data backup activity, data restoration and its compliance. To ensure timely completion of CAPAs and to perform change control/CAPA effectiveness. For all the positions, candidate should have exposure in pharmaceutical company and exposure to regulatory requirements of documentation and cGMP will be added advantage. Interested candidates Please Walk-in for an interview along-with their Aadhar Card, Passport size Photograph, updated CVs, Salary Structure, Salary Slip and relevant documents(original as well as Photocopies) as per the schedule.

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4.0 - 7.0 years

3 - 6 Lacs

Ankleshwar

Work from Office

Location: Ankleshwar Department: Quality Control Experience: 4 to 7 years Position : Executive Job Description: We are looking for a skilled HPLC Analyst (Executive QC) who will be responsible for ensuring quality compliance in laboratory testing of pharmaceutical raw materials, intermediates, finished goods, and stability samples. Key Responsibilities: Adhere to GLP (Good Laboratory Practices) and laboratory safety protocols . Perform routine and stability analysis of raw materials, intermediates, finished products, in-process samples , returned goods, hold time studies using HPLC . Maintain online documentation and ensure CFR 21 Part 11 compliance. Record and maintain analytical results in worksheets and LIMS modules. Conduct analysis as per current STP, SOPs, and specifications . Prepare and standardize reagents, solutions, and mobile phases as per requirement. Ensure column performance is tracked and updated in column logbooks . Maintain instrument logbooks , calibration schedules, and instrument history records . Participate in analytical method transfer (AMT) with A.R. laboratory teams. Prepare stability protocols and reports , and perform stability sample analysis . Monitor temperature & humidity of laboratory, refrigerators, and working standard chambers. Report and initiate investigations for OOS, OOT, Deviation, QI, NQI, and discrepancies in analysis. Follow Good Chromatographic Practices for integration and review of chromatographic data. Ensure data integrity and compliance during all analytical activities. Communicate and coordinate with stores for urgent material analysis. Avoid solvent/chemical wastage and ensure clean laboratory operations. Interested candidate please fill the below given link: https://docs.google.com/forms/d/e/1FAIpQLScDxs_rRkTFo3l4kQNsy9oij5XXDEi4ztPPsIbwxHvGaLaKbA/viewform?usp=header

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0.0 - 3.0 years

0 Lacs

chennai, tamil nadu

On-site

As a highly motivated scientist joining our dynamic research team, you will be required to have an educational qualification of M.Pharm / M.Sc. (Chemistry) and possess extensive basic knowledge of modern analytical techniques. Your role will involve analyzing raw materials, in-process, and finished products while generating analytical data with accuracy and adequacy. You will be responsible for the preparation of reference, working, and impurity standards, ensuring the timely completion of assigned training modules, and maintaining the availability of consumables for experimental activities. Your expertise in handling analytical techniques such as Spectroscopy (UV-Vis, FT-IR), Chromatography (HPLC), and other instruments like Potentiometric titrator and KF will be vital for this role. Additionally, you should have knowledge of method development, stability analysis, cGMP, GLP, and GDP procedures. Understanding development activities and processes in the pharmaceutical industry is essential, along with maintaining accurate records of research activities and results. You will play a key role in maintaining a safety and quality culture, participating in lab activities to ensure compliance, and following appropriate safety practices in the workplace. It is important to actively contribute to achieving team goals, communicate information clearly and impartially, and enforce safety requirements related to your job function. This position is based on-premise, and Pfizer is an equal opportunity employer that complies with all applicable equal employment opportunity legislation. If you are a motivated scientist with a background in pharmaceutical research and the required educational qualifications and experience, we encourage you to apply to be part of our Research and Development team.,

Posted 6 days ago

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5.0 - 9.0 years

0 Lacs

karnataka

On-site

You will be responsible for liaising between various departments such as Planning, Production, Technical Services, Marketing, and Exports. Your roles and responsibilities will include the preparation, review, and implementation of SOPs and STPs. You will be checking all QC related records like analytical reports and logbooks. Additionally, you will be involved in planning and distributing samples for the analysis of Raw Materials, Intermediates, and finished products. You will design and conduct Stability studies as per ICH Guidelines and develop and validate analytical testing methodology used to control raw materials, production intermediates, and final products. Your tasks will also include the preparation and maintenance of working standards with documents, as well as the operation and calibration of laboratory instruments like HPLC, GC, and Spectrophotometer. You will review and approve Raw material, finished product, and Packaging material specifications. Furthermore, you will be responsible for handling customer audits and regulatory authority audits and preparing compliance reports. Troubleshooting of HPLC, GC, and other instruments will be part of your responsibilities. You will manage the laboratory and work towards analytical laboratory improvement, cGMP and GLP compliance, and problem resolution. As the QA/QC Manager, you will be solely responsible for exports and quality-related issues for the unit. You will supervise QC chemists to ensure the smooth working of the department and to guarantee the best quality of products from the production. This is a Full Time position located in Byrathi, Bangalore.,

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10.0 - 16.0 years

0 Lacs

karnataka

On-site

Seeking a skilled professional with 10-16 years of experience in Protein/Peptide Purification to lead and oversee a team. The ideal candidate will excel in purification techniques, leadership, experiment planning, data analysis, mentoring, troubleshooting, scale-up, and cost improvement. As the Peptide Purification Lead at the managerial level, you will be responsible for leading daily operations in the peptide purification lab, managing workflows from milligram to gram scale. Your role will involve supervising and mentoring a team, assigning tasks, troubleshooting, and fostering skill development. You will be expected to analyze experimental data such as chromatographic profiles, purity, and yield, and generate technical reports. Additionally, you will manage laboratory budgeting and costing for purification activities, plan and schedule purification experiments, and be involved in downstream process development and scale-up activities related to peptide/protein purification. To be successful in this role, you must possess in-depth knowledge of peptide chemistry and purification methods, as well as a good understanding of downstream processing and the unit operations involved in peptide/protein purification. You should have experience in using statistical tools for Design of Experiments (DoE) and Quality by Design (QbD) in the process development of peptides/proteins. Utilizing analytical thinking and data interpretation skills will be key to your success, along with familiarity with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory standards. The qualifications and experience required for this position include an M. Tech or PhD in Chemistry, Biochemistry, or a related field, along with 10-16 years of experience in a Protein/Peptide Purification role. If you meet these criteria and are interested in this opportunity, please send your CV to rashmi.gupta@biocon.com. In your CV, please include your experience in Peptide Purification and the total number of years you have worked in this field, your current Cost to Company (CTC), Notice Period, and Qualifications. Please note that this is an onsite job located in Bangalore, requiring your presence five days a week.,

Posted 6 days ago

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