QA Manager - Injectables

Role & responsibilities

Monitoring & Review of sterility Assurance data and media fill activities.

Investigation of Non-conformance and deviations and determining the acceptability of each batch for release disposition.

Handling of SAP, LMS, EDAMS, BRMS, EDMS and LIMS and Lonza-Moda, E-log related activity as per assigned rights.

Review and Approval of QMS related documents i.e. Incidents & Investigations, CAPA, Change Control, CAPA effectiveness check, Market complaints etc.

Perform Risk Assessment and assign RPN nos.

Execution and monitoring of Process validation, Cleaning Validation, Cleaning Verification and continuous process verification.

Handling of area qualification & smoke test activity.  Review of breakdown activity.

Quality Compliance Related Activity.

Handling of any additional activities / tasks allotted by department head.

Reviewing and approving procedures and associated records for various manufacturing and quality activities, protocols/ reports for process validation, cleaning validation/verification, Continuous process verification and any other GMP documents.

Sign / Approval of cGMP documents as QA Head designee as and when required.

Evaluation of product robustness and preparation or product assessment reports and Product Understanding Reports.

Conducting internal and external audits as required to assure compliance to regulatory expectations and internal policies, standards and procedures.

Skills : USFDA / Injectables