QA – Process Validation | Gufic Group | Navsari

Job Description

• Responsible to prepare process validation and Bulk hold Time Study protocol and report.
• Responsible for execution and compilation of Process Validation and Bulk hold time study as per protocol.
• Responsible for maintaining and tracking the Process validation and Product bulk hold time study status
• Responsible to initiate / check / handle Quality management system documents i.e. Change Control / Deviation / Incident / OOS/ OOT / CAPA.
• Responsible for preparation of Annual Product Quality Review.
• Responsible for providing line clearance during various processing stages i.e. Decartoning/Dispensing /Visual inspection/Packaging etc. and to carry out In-process checks of pre-determined process parameters.
• Responsible for coordination with internal as well as external department personnel.
• To prepare and review standard operating procedures.
• Responsible to maintain the document as per cGMP.
• Responsible for issuance of documents & maintain records.
• Responsible to provide the documents to the regulatory department.
• Responsible to execute / compilation any assigned validation activity.
• Any other responsibility assigned by the In-charge/Head of the department.

Desired Candidate Profile

• Candidate having a background in Injectable
• The candidate should be a Versatile
• Having deep knowledge of Process Validation

Perks and Benefits

• Medical Benefits Incl. family
• PF and Gratuity Benefits
• Accommodation facility for Bachelors

Qualification: B.Pharma, M.Pharma, MS/M.Sc