244 Oot Jobs - Page 3

Responsibilities: To impart the departmental training & co-ordinate for cGMP training as per planned schedule. To Coordination of Regulatory/Customer audit and its compliance. Review the audit feedback and provide the action plan for compliance of audit observation/ findings. To perform self-inspection for all respective departments & evaluate the compliance of any reported non-compliance in the self-inspection report. To review the deviation, change control, incident for impact on product quality and safety in QAMS. Perform risk assessment for risk reduction/mitigation at acceptance label for product & QMS related documents as part of impact assessment. Review of QA documents, review of spe...

Job Title: Senior Officer – Process Engineering Business Unit: Engineering Job Grade G12B Location : Gangtok 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: Execution of Breakdown maintenance...

Date: 15 Sept 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Development Services Job Title: Sterile Manufacturing, Filling Supervisor Department: Formulation production Job Location: Bengaluru, India About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit. M...

The ideal candidate brings 8 to 10 year and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Additional info: Key Skills: QMS (Change Control, Deviation...

The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Additional info: Key Skills: DMF Compilation, QA Coordinat...

Micro Head based in Kathua, Jammu & Kashmir. The ideal candidate brings 12 - 15 yrs exp. and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Lead mi...

Assistant Manager / Sr. Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improveme...

HVAC & Water System Engineers 2 Posts based in Amritsar. The ideal candidate brings 2 - 4 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen)...

Assistant Manager QA 1 Pos based in Amritsar. The ideal candidate brings 8-10 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Strengthen...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 8 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Le...

Quality Assurance (QA) based in Latur The ideal candidate brings 0-1years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Strengthen QMS: author/re...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat The ideal candidate brings 5 to 8 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/...

QC Head 1 Pos based in Kathua, Jammu & Kashmir. The ideal candidate brings 12 - 15 yrs exp. and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Mana...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5-8 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/...

Role & responsibilities Independently handle the (QMS) change control, Risk Assessment, Deviation, Investigation, CAPA implementation, OOS, OOT, OOL Investigation, Process validation Protocol and report preparation, Internal and external audit compliance. Candidate having technical knowledge injectable manufacturing and water system. Knowledge of QMS Standards: Familiarity with ISO 9001, AS9100, or other relevant standards is essential. Internal & External Auditing: Ability to conduct audits, prepare reports, and ensure corrective actions are implemented. Process Improvement Tools: Proficiency in Six Sigma, Lean, and Total Quality Management (TQM) methodologies. Quality Core Tools: Expertise...

Ensure Site Quality control, investigation related to OOS, OOT deviations, laboratory incidents, customer complaints and CAPA.Sampling and analysis of Raw materials-APIs, intermediates, solvents and finished products of plant/commercial batches. Required Candidate profile Msc/MPharm), working in API Unit,aware of cGMP, USFDA regulations (21CFR),ICH-guidelines, process and cleaning validation protocols,online manufacturing compliance with regulatory requirements.

Job Title: Integration Specialist – LIMS Job Grade: G11A/ G11B Function: Global IT/Projects Location: Baroda 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.” Position Summary: Integration Spec...

Walk-in drive: Senior Chemist / Junior Research Associate - HPLC Analytical Method Validations Work Location: Hyderabad Eligibility: Must have 1 to 3 Years of experience in Analytical Method Validations by using HPLC for Formulation products. M.Sc. / M-Pharmacy or Equivalent Qualification. Job Description : Analytical method validations and method transfer as per cGMP requirements for drug products. Strong experience in handling various analytical instruments like HPLC, UPLC, UV and Dissolution USP type-I and II and type-IV. Dissolution, Assay and Related Substances method validationand method development of finished products like Tablets, Capsules, Pellets, oral suspensions and Injectables ...

Role & responsibilities Adequate knowledge of respective guidelines. i.e. ICH, USP,WHO, etc. Stability sample analysis by HPLC/GC/UV/Dissolution apparatus. Preparation of stability testing worksheets. Sample charge and withdrawal as per stability condition. Management of stability samples and stability chambers and maintain the schedule. Preparation of stability trend records and summarize the results Review the stability sample testing data. Review the stability analysis worksheet. Review the stability protocols, samples and stability chambers log records. Review of OOS/OOT and co-ordinate with respective concerns.

Job Description Maintenance of GLP in the Laboratory Upkeep of Housekeeping in the Laboratory. Ensuring activity logs are maintained for all critical instruments /equipment’s. Timely preparation of Laboratory Documents. Timely review of analytical data generated in laboratory. Ensuring Analytical Technology transfer from transferring lab as per approved protocol. Review and approval of incident , out of specification ,out of trend report and approval of QC related activities. Involved in QAMS activities such as change control, CAPA , incidents, deviation etc. Approval of stability summery report. Timely review of Quality control procedures and initiation for up gradation of same. Compliance ...

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 ...

Overview POSITION SUMMARY STATEMENT This position is having the primary purpose of ensuring compliance to the Herbalife requirements and adherence to HLF's global procedures in Quality assurance and control during the manufacturing and storage of Herbalife products in the Contract manufacturing location in India. How You Would Contribute Monitoring of process on set frequencies to ascertain compliance to Herbalife Quality procedure requirements Conduct periodic audits of the facility and operations associated with Herbalife, to help CM meet and improve the quality and hygiene standards as per Herbalife Quality standards, Ministry of Ayush, Ayurveda product standard and FSSAI GMP Guidelines. ...

HI, We have an opening for Assistant Manager - QC (Analytical Reviewer & QMS) in Nerul, Navi Mumbai Location. Experience - 10 - 15 yrs Qualification - M.Sc. (Chemistry/Analytical Chemistry) Interested Candidate may forward his resume on ankit02.kumar@usv.in Job Responsibilities: 1. Review of Logbooks, Test data sheets, and data generated in Quality control Analytical department. 2. Routine inspection of Quality control department to check and ensure compliance as per cGMP. 3. Routine inspection of QC schedule for execution. 4. Preparation and review of protocol and report for validation, verification, Characterization, hypothetical testing and Force degradation studies. 5. Initiation of devi...

Job Title: Senior Executive – R&D Quality, CMC QA (Analytical) Business Unit: Global Quality & Compliance Job Grade G11B Location : Gurugram 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: Rev...

Quality Control (QC) investigators are responsible for analyzing and investigating deviations from specifications, such as out-of-specification (OOS) test results complaints, and potential quality issues Required Candidate profile identified during manufacturing, which ensures product quality, safety, and regulatory compliance.