Manager Quality Assurance
Job Summary
JOB DESCRIPTION:
Qualification : B Pharm/ M. Pharm
Experience : 15 to 20 years.
Job Responsibilities
- Ensure compliance of all procedures practices and system to cGMP with respect to Schedule M. WHO guidelines Abbott Quality guideline and Standard operating procedures at site.
- Responsible for QMS.
- To review and approve the investigation reports of Exception and market complaint.
- To review and approve the change control planned deviation in track wise.
- To review and approve the site complaint investigation and accountable for timely closure of site complaints.
- To review the CAPA and track its implementation within the timeframe. To check the effectiveness of CAPA implemented.
- To monitor the site internal audit program and its compliance. Participation as an Auditor in internal audit.
- To ensure implementation of EQD Policies on site within the given timeframe.
- Management of Document issuance and archival.
- To review and approve site SOP specification documents in DARIUS.
- Review of product quality review evaluation of product trends.
- To ensure implementation of site training management activities.
- Management of control sample activities.
- Monitoring of Batch records preparation and review of master batch records.
- Handling and management of QRM program at site.
- Management of Supplier Complaint and Service Providers.
- To deliver the training at site on GMP topics SOPs and other technical topics.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EPD Established Pharma
LOCATION:
India > Salcette : Goa Factory
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Required Experience:
Manager
Key Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more