Ami Lifesciences was incorporated with the goal of changing the way in which quality medicines are delivered to people in need. We operate on the principle by extending our focus and services to maximize our impact on the global pharmaceutical industry.
We have spent last two decades in building up our scientific and technological capabilities, research, and manufacturing competencies. Along the way we have earned a reputation for being innovative, inventive, and resourceful. We have built long term business association pharmaceutical companies of the world.
2 – 7 years
Not Disclosed
Time and Venue
6th April , 9.00 AM – 4.00 PM
Hotel Lords Plaza, C-4/6, Old National Highway-8, Ankleshwar
Contact – Swati Pandita
Job description
Role & responsibilities
Quality Control
1. Attending regulatory and customer audits.
2. Preparation and implementation of SOPs as per regulatory requirements.
3. Evaluating training needs of teams & conducting GMP, GLP & other training programs for employees across levels & functions.
4. Conducting basic GMP, refreshing/updating GMP training to all company employees.
5. Supervising the quality audit process for RM & PM vendors, contract manufacturing sites & third-party sites.
6. Preparing sample management system for control, validation, stability & market/customer samples
7. Overseeing dossier preparation and filing, planning, preparation, review, and evaluation of related documents
Quality Assurance
- To prepare Annual Product Quality Report.
- Review and handling of Change control.
- Handling of Training related software (CAMS) and execution.
- To involve in validation of Training manager software (CAMS)
- Preparation of Quality Assurance SOPs.
- Review of executed batch manufacturing and batch packing record and analytical
protocol. - To prepare product process validation protocol and report.
- Overall handling and leader of document cell department.
- To prepare Quality Management Review meeting report.
- To fill Vendor questionnaires
Preferred candidate profile
1. Must have experience in API Industries
2. Must have knowledge of HPLC, GC system
Perks and benefits
Bus & Canteen Facility Available
Role:
Quality Assurance – OtherIndustry Type:
Pharmaceutical & Life SciencesDepartment:
Quality AssuranceEmployment Type:
Full Time, PermanentRole Category:
Quality Assurance – Other
Education:
MS/M.Sc(Science) in Organic Chemistry
