21 Aug
|
Habitare Pharma
|
Barwala
21 Aug
Habitare Pharma
Barwala
Habitare Pharmaceuticals Private Limited is a premier third-party pharmaceutical product manufacturing company, specializing in Non-Beta Tablets, Capsules, Oral Liquids, External Applications, Ointments, Gels, Medicated Creams, Lotions, and more.
Roles and Responsibility:
Ensure compliance with cGMP, GLP, GDP, WHO, ICH, and regulatory guidelines.
Establish, implement, and monitor Quality Management Systems (QMS).
Oversee batch release, documentation control, and product quality reviews.
Documentation & SOP Management
Create, review, and approve SOPs, validation protocols, batch manufacturing records, and related documents.
Ensure proper document control, revision management, and archival practices.
Compliance & Regulatory Support
Prepare for and actively participate in regulatory audits (FDA, WHO, GMP, ISO, State FDA etc.).
Coordinate internal and external audits & ensure timely closure of observations (CAPA management).
Review regulatory submissions related to QA.
QMS (Quality Management System) Management
Responsible for change control,
deviation management, OOS/OOT investigations, and preventive actions.
Ensure timely investigation and root cause analysis.
Maintain risk assessment and mitigation processes.
Batch Release & Review
Review batch manufacturing and packing records for accuracy and completeness.
Approve batches for release, ensuring compliance with specifications.
Oversee raw material, in-process, and finished product quality assurance activities.
Training & Team Management
Train plant personnel on GMP, SOPs, quality standards, and best practices.
Lead and mentor QA team members.
Promote a solid culture of quality across departments.
Validation & Qualification
Oversee equipment qualification (DQ/IQ/OQ/PQ) and validation of utilities, processes, cleaning, and analytical methods.
Approve validation protocols and reports.
Vendor & Material Quality Assurance
Approve and audit suppliers of
📌 Manufacturing Chemist Barwala
🏢 Habitare Pharma
📍 Barwala