Job Description

Roles and Responsibilities

• Review and approval of Master BPCR, master ECR, SOP and Protocols.
• Review and approval of Process Validation and cleaning validation protocols and reports.
• Responsible for internal audit and compliance for all the applicable departments at this site.
• Responsible for External Audit preparation and its compliance with respect to regulatory and customer and preparation of audit.
• Review and approval of deviation, change control, CAPA,OOS,OOT & APQRS.
• Responsible and monitoring and ensure the compliance of plant GMP activity.
• Review and approval of qualification ( i.e. URS, DQ,IQ,OQ,PQ) of equipment and instrument.
• Responsible of CAPA effectively evaluation and review of CAPA trend analysis.
• Review and approval of stability study, hold time study, method validation, photo stability study, humidity study.
• Responsible to release, allocation and distribution of API and saleable intermediate batches.
• Responsible for qualification of vendor and approved vendor list verification and perform, vendor audit at vendor site. Filled the vendor questionnaire and control the documents.
• Responsible for CGMP, Functional and On job training and management and its compliance.
• Release and rejection of all the batches of saleable intermediates and finished product.
• Responsible for compliance of preventive maintenance schedule and calibration activity.
• Responsible for review and approval of plant layouts and facility layouts.
• Responsible for ensure the compliance of equipment and instrument calibration activity.
• Responsible for review of product technology transfer report.
• Handling of market complaint and product return good and recall
• Responsible for compliance of plant GMP activity.

Desired Candidate Profile

• Candidate with exposure in API must
• Qualification: M.Sc.Chemistry / M.Pharma
• Experience: 10 to 15 years in API Industry only

Perks and Benefits



Role:Quality Assurance - Other Salary: 10,00,000 - 17,00,000 P.A. Industry:Pharmaceutical & Life Sciences Functional AreaQuality Assurance Role CategoryQuality Assurance - Other Employment Type:Full Time, Permanent

Key Skills
Quality Assurance
qainstrument calibration
Skills highlighted with \xe2\x80\x98\xe2\x80\x98 are preferred keyskills
Education PG:MS/M.Sc(Science) in Any Specialization,M.Pharma in Any Specialization

Company Profile

Ami Lifesciences
Ami Lifesciences was founded 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.