2.0 - 3.0 years

0 - 1 Lacs

Sanand

Work from Office

Role & responsibilities Maintain site Annual validation Plan & track activities as per Validation Plan. Tracking & follow-up on Validation & Change Control records at site. Coordinate for eQMS records (Investigation, CAPA, effectiveness checks) closure at site. Monthly trending of Non-Conformance records at site. Data update for Daily & Monthly Quality meetings. Govern Global SOPs compliance at site. Manage periodic review of documents (SOPs, attachments, forms etc) at site. Vendor complaints: Handle vendor complaints at site for getting actions closed at site & with suppliers for on time closure. Training: Ensuring completion of site trainings as per training calendar at site. Work with Sit...

Posted 7 months ago

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Quality Compliance support Ashkom

1.0 - 2.0 years

0 - 1 Lacs

Sanand

Work from Office

Key Roles & Responsibilities : The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The individual must have good communication skill with team, team-work capabilities, patience to work under pressure. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software. Maintain site Annual validation Plan & track activities as per Validation Plan. Tracking & follow-up on Validation & Change Control records at site. Coordinate for eQMS records (Investigation, CAPA, effectiveness checks) closure at site. Monthly ...

Posted 7 months ago

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Manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Ocugen

8 - 10 years

12 - 15 Lacs

Hyderabad

Work from Office

Job title manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Reports to Head of Quality Assurance (GMP and GCP) Job purpose Our Quality team is growing, and we are currently seeking a Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our clinical and commercial manufacturing processes. Reporting to the Head of QA, the Manager will oversee a team responsible for manufacturing, batch record release, investigations, deviations, CAPAs (Corrective and Preventive Actions), change controls, analytical methods, stability programs, and auditing within our GMP operations. Duties and responsibilities QA managers define and implement quality sta...

Posted 7 months ago

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