Manager Quality Assurance
Job Summary
JOB DESCRIPTION:
Minimum Qualification: M. Pharma/ B. Pharma/.
Candiate shall be well versed with manufacturing and packaging operations Compression Machines Isolators Blenders Bulk packing lines & Process Validation.
Followings will be the responsibilities of the position holder:
To ensure compliance of current Good Manufacturing Practices in the Hormone facility & to follow GDP with data-integrity compliance.
Preparation and review of qualification and Validation documents (URS DQ IQ OQ PQ etc.) for Hormone facility.
Preparation review and approval of process validation and cleaning validation protocols for Hormone facility.
Management of control sample Preparation updating review and approval of Validation Master Plan Site Master File Quality Manual for Hormone ordination with other departments for streamlining qualification validation IPQA and QMS activities for Hormone facility. Handling of QMS activities (Change Control Exceptions CAPA Market complaints) for Hormone Facility. Batch release Responsible for review of the executed batch documents and release of finished product for Hormone Facility.
To ensure effective working of In-process Quality Assurance activities including ensuring calibration of IPQA instruments as per schedule for Hormone Facility. Preparation and review of APQR.
To review and approve batch records of Hormone Facility. To conduct self-inspection/ internal audit as per site Internal Audit Program.
To investigate and provide CAPA for self-inspection/ internal audit and external audit -ordination with Service providers for the qualification / validation activities. Qualification of service providers for Hormone Facility. Review of Calibration and Preventive Maintenance related documents.
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 > Village Mauza : Baddi
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
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