Dy Mgr/ Mgr/ Sr Mgr- Quality For Api Unit Job in Akums Drugs & Pharmaceuticals Ltd.

QUALITY MANAGEMENT SYSTEM:

• Implementation of Quality Management System at site.
• Ensure compliance to Current Good Manufacturing Practices (CGMP).
• Overall responsible for compliance to in-house and contract projects with respect to Manufacturing.
• Responsible for closing the OOS reports by providing proper technical justification including a suitable CAPA.
• Responsible for performing product reviews.

TRAININGS:

• Ensuring training to all employees as per the schedule and imparting training to shop floor personnel as well.
• Reviewing the training records and assessment sheets

INTERNAL AUDITS:

• Ensure that the internal audits (self-inspections) are performed as per the schedule.
• Responsible to make sure that all the critical deviations are investigated and resolved.

SOPs and APPROVALS:

• Responsible for approving all departmental SOP s.
• Responsible for reviewing specifications of raw materials, in-process, intermediate and finished drug substances, packing materials, labeling materials and standard test procedures.
• Responsible for approving process validation, cleaning validation, purified water system validation, HVAC, Hold time stability protocols and reports.
• Review and approve qualification protocols of instrument/equipment, Analytical method transfer protocols and reports.

MANUFACTURING SUPPORT:

• Responsible for reviewing and approval of scale-up, technology transfer and development reports.
• Responsible for maintaining online documentation
• Responsible for reviewing, identifying the gaps and support to complete the executed batch records
• Responsible for reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution.
• Responsible for releasing or rejecting all API s and Intermediates.
• Responsible for approving intermediate and API contract manufacturers.
• Responsible for approving changes that potentially impact intermediate or API quality.

OTHERS:

• Responsible for acting as Quality Management Representative in the site.
• Responsible for delegating works to In-Charge-QA in his absence.
• REGULATORY/CUSTOMER AUDITS:
• Responsible for all regulatory audits such as USFDA, EDQM, MHRA, KFDA, ANVISA, PMDA and TGA as a prime auditee.
• Responsible for customer audits and ensuring to get minimum observations, specifically without any major/critical observations that may lead to data integrity.
• Should able to handle the audits independently and is accountable to respond on all regulatory queries.