349 Who Jobs

Position Overview JOB DESCRIPTION The Assistant General Manager Projects (API Pharma) will be responsible for leading and managing end-to-end project activities for Greenfield and Brownfield API (Active Pharmaceutical Ingredient) manufacturing facilities across domestic and international locations. The incumbent will oversee all phases of the project lifecycleconceptualization, design, engineering, procurement, construction, installation, commissioning, and handoverensuring timely delivery, adherence to budget, and full compliance with cGMP , EHS , and regulatory standards. This role requires a highly skilled project management professional with a strong background in pharmaceutical engineer...

We are seeking a detail-oriented and proactive Regulatory Officer to ensure compliance with all applicable regulatory standards. The candidate will be responsible for preparing regulatory submissions, maintaining documentation, coordinating across departments, and ensuring that company processes and products meet regulatory requirements. Key Responsibilities Prepare, compile, and submit regulatory dossiers and documents to authorities (e.g., CDSCO, FDA, BIS, pollution control boards). Manage product licensing, registration, and renewal processes. Maintain regulatory documentation, compliance records, and databases. Ensure all product labels, packaging, and artworks comply with regulatory nor...

knowledge and handling of HPLC and GC instrument activities knowledge and handling of Wet analysis (LOD, SOR, WC and TLC) activities Testing and knowledge HPLC and GC instrument analysis Testing and knowledge of Wet analysis (LOD, SOR, WC and TLC) Computer knowledge Understanding of regulatory guidelines (ICH, USFDA, MHRA, WHO, etc.). Ability to work in a team and coordinate with cross-functional departments. Good communication skills and ability to present analytical findings.

Roles and Responsibilities Plan production activities to meet customer requirements, ensuring compliance with GMP guidelines. Coordinate with various departments (QA, QC, Packing) for smooth plant operations. Ensure timely availability of raw materials and packaging materials through effective planning and coordination. Monitor daily production planning, shift planning, and manpower handling to achieve productivity targets. Oversee blister packing, granulation, compression machine operation, WHO inspections, and tablet/capsule filling processes. Desired Candidate Profile 10-12 years of experience in pharmaceutical production management or related field. Bachelor's degree in Pharmacy (B.Pharm...

Candidate from Ahmedabad Only Assist in the production for tablets, capsules, & liquids, ensuring compliance with cGMP guidelines, SOPs, and regulatory requirements. Batch Manufacturing In-Process Quality Control Documentation and Record-Keeping

Manage daily manufacturing operations Maintain strict compliance with ISO 13485, GMP, and medical device regulation Lead and supervise production teams, ensuring training and discipline Oversee quality control, documentation, batch records, and audit Required Candidate profile Ensure machine maintenance, calibration & cleanroom Monitor raw material inventory, reduce wastage, and optimize resources Coordinate with QA, R&D, Supply Chain, and management for smooth operations

Walk In Drive Quality Assurance Department In Formulation Division @ Elite Hotel ( MANJEERA HOTELS AND RESORTS) Department :- Quality Assurance OSD Qualification :- B Pharmacy | M Pharmacy | MSC Chemistry Experience :- 2 to 8 Years Division :- Formulation Interview Date:- 07-12-2025 Interview Time:- 9AM TO 2.00PM Work Location :- MSNF-II, Kothur Venue Location:- Elite Hotel ( MANJEERA HOTELS AND RESORTS) NH 44, Hyderabad - Bangalore Highway, Jadcherla, Macharam, Telangana 509301 Contact No:- 040-30438701 | 070970 92829 | Note:- Candidate should bring Update Resume ,Increment Letter,Payslips, Bank Statement, Certificates,Aadhar Card & Pan Card We are looking for candidates those who have expe...

1. Biosimilar Regulated market submissions - US / EU injectable market submission. 2. Biosimilar Product Development Strategy for CMC and Clinical. 3. Review of all Dosisier related Quality documents including coordination with Cross functional teams ( RD, QC/QA and Manufacturing). 4. Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions. 5. MOH Query response. 6. Biosimilar Product Life Cycle Management. 7. RA support for Plant related QMS activities.

1. Biosimilar Regulated market submissions - US / EU market submission. Preferred US FDA .Alternatively candidates having exp in Small molecules and injectables for US. 2. Should Have dossier authoring for CMC for EU market. 3. Should have authoring of pre approval dossiers and query responses for US and EU. 4. Biosimilar Product Development Strategy for CMC and Clinical trials 5. Review of all Dossier related Quality documents including coordination with Cross functional teams ( RD, QC/QA and Manufacturing) . 6. Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions 7. MOH Query response. 8. Biosimilar Product Life cycle Management. 9. RA support for Plant related ...

Qualification - BSC- Nursing, Pbsc Nursing Infection Prevention Policies: Develop, implement and update infection prevention policies and procedures in compliance with relevant guidelines and regulations. Education and Training: Provide education and training to hospital staff, including nurses, physicians and support staff, regarding infection control principles, practices and prevention strategies. Surveillance: Monitor and analyze infection rates within the hospital, conducting surveillance of healthcare-associated infections to identify trends and areas of concern. Isolation Protocols: Establish and enforce isolation protocols for patients with contagious diseases, ensuring proper precau...

Oversee the formulation, blending, and packaging processes in compliance with GMP and industry regulations Ensure adherence to quality control standards, safety norms, and environmental regulations Optimize resource utilization Required Candidate profile Coordinate with R&D, QA/QC, and supply chain teams for smooth product flow. Liaise with management on production planning, reporting, and audits. Maintain documentation as per regulatory guidelines.

Be responsible for managing regulatory submissions in terms of collection of data, review of site variations Be up-to-date with Guidance and MHRA & EU Regulations and provide assistance in evaluating proposed changes and deciding strategy, BE study queries Post approval change management To assist in thorough interpreting of RFIs, and outlining plan of action to respond to deficiencies To provide support/assistance to UK RA team by coordinating with suppliers/CMOs on Regulatory matters

Job Title: Executive – Regulatory & Business Continuity Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location Baroda 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.” Job Description: Preparation of registra...

Hands-on experience in monitoring manufacturing and packaging processes, line clearance, and in-process checks. Proficiency in DOC-MS systems, SOP preparation, deviation handling, and change control. Involvement in TT activities including protocol review, execution, and coordination between RCD and manufacturing. Familiarity with validated software systems that meet FDA electronic records and signatures requirements. Strong understanding of equipment qualification (D, I, O, P), process validation, and cleaning validation. E-BMR G E-Log: Experience with electronic Batch Manufacturing Records and Logbooks for real-time documentation and traceability. uality Management Systems (MS): Implementat...

Role & responsibilities The QA & Regulatory Affairs Manager leads and oversees all regulatory and quality assurance activities within the company, ensuring that all products comply with local and international medical device regulations . The role is responsible for developing and executing regulatory strategies , managing submissions and approvals , and maintaining strong relationships with health authorities, notified bodies, and certification agencies to support product launches and lifecycle management. A core aspect of this position is to build and implement a full Quality Management System (QMS) compliant with ISO 13485:2016 , and to ensure regulatory readiness for global markets inclu...

As a Validation Specialist at our company, your role will involve ensuring that the validation system remains updated according to regulatory requirements and industry standards. You will be responsible for executing and reviewing Qualification/Re-Qualification and Validation activities for Equipment/System/Facility and Plant utilities. Your coordination with manufacturing, Engineering, and QC personnel will be crucial for the timely completion of Qualification/Validation/Re-qualification activities. Additionally, you will be preparing Standard Operating Procedures for the Quality Assurance Department and conducting sampling activities as per protocols such as Process Validation and Cleaning...

Utility Operator HVAC / Water / Electrical (01 Position) based in Vapi, Gujarat. The ideal candidate brings 5 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 improvemen...

The ideal candidate brings 15-20 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). Plan resources, ensure statutory compliance, drive traini...

The ideal candidate brings 3- 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/Kaizen). Own production execution and shift supervision; ensure lin...

The ideal candidate brings 5 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) Own production execution and shift supervision; ensure line clea...

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...

The ideal candidate brings 10- 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 microbiology practices including EM, MLT, sterility ...

The ideal candidate brings 15-20 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). Plan resources, ensure statutory compliance, drive traini...

The ideal candidate brings 2 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 QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA,...