7 Eugmp Jobs

Role Overview: You will be responsible for leading end-to-end execution of greenfield/brownfield injectable facility projects. This includes covering design, budgeting, procurement, construction, commissioning, and qualification. Your main focus will be on ensuring uninterrupted and compliant operation of critical utilities such as WFI, Pure Steam, RODI, HVAC, Compressed Air, Nitrogen, and chilled water systems. Key Responsibilities: - Ensure all systems and documentation meet cGMP, GEP, and regulatory standards like USFDA, EU-GMP, WHO-GMP. - Prepare for and support audits and inspections, collaborating with QA, Production, Validation, and EHS teams. - Manage third-party vendors, consultants...

This role is responsible for technology transfer, process scale-up, equipment selection, and process validation in API manufacturing. The position ensures that the selected equipment aligns with process requirements, product quality, safety, and regulatory compliance, while supporting continuous improvement and operational excellence. Key Responsibilities: 1. Technology Transfer & Scale-up Lead the transfer of chemical processes from R&D to manufacturing. Evaluate and optimize process parameters for scale-up using mass and energy balances. Collaborate with Engineering for facility fitment, equipment readiness, and plant execution. 2. Equipment Selection & Sizing Analyse process requirements ...

Ensures Products meet established standards by developing and implementing quality control procedures, conducting audits, monitoring performance metrics, and resolving quality issues. Maintain documentation, Ensure compliance with Pharma regulations Required Candidate profile M.Sc - B. Pharma - M. Pharma - BE - Chemical Good knowledge Of Quality Assurance Good Command over English And Computer Must be ready to face customers Inquiries And Local And US FDA Authority

As the Head of Quality Control at a leading Pharma MNC located in the Chandigarh Vicinity, you will be responsible for overseeing the quality control operations of highly regulated plants, specifically focusing on tablet/capsule/pallets/OSD products with a preference for injections. With over 20 years of experience in the industry, you will demonstrate a track record of excellence in maintaining MHRA and EUGMP profiles, along with multiple successful audit exposures. In the realm of Quality Assurance, you will showcase a deep understanding of the latest updates outlined in the ICH Q9 guidelines. For Quality Control, you will exhibit proficiency in the Updates related to ICH Q2R2 Analytical m...

The position of Head of Quality Assurance at a Leading Pharma MNC in Chandigarh Vicinity offers a competitive salary of up to 60 LPA. As a qualified candidate, you must possess over 20 years of experience in managing highly regulated plants, with a strong focus on Tablet/capsule/pallets/OSD products, and preferably injections as well. Your expertise should include an excellent MHRA and EUGMP Profile, along with a track record of multiple successful audit exposures. In the realm of Quality Assurance (QA), you are expected to be well-versed with the latest updates in ICH Q9 guidelines. Additionally, in Quality Control (QC), familiarity with Updates in ICH Q2R2 Analytical method validation is c...

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports.

Expertise in API / Formulation regulatory compliance across EU/ROW regions Sound knowledge of Drug Substance control strategies Familiarity with global regulations: ICH, FDA, EMA, USFDA etc Skilled in responding to Ministry of Health (MoH) queries Required Candidate profile M. Pharma / B. Pharma / M.Sc / B.Sc with 7 to 15 Years Experience Deep Knowledge of Regulatory Affairs Compliance And Procedures Must be able to work independently And Head Team of junior Officers