Head qaqc

Job Description

i) Documentation (Review and Approve):

• Design and development of documentation system for preparation, review and approval of documents such as SOPs, Batch Manufacturing Record, Batch analytical record, Department Manual, Site Master File (SMF), Validation Master Plan (VMP) etc.
• Reviewing and approving all procedures, validation documents and qualification documents.
• Making sure that Validation Master Plan is effective to cover all the qualification, requalification and calibration activities are conducted within due dates.
• Releasing manufactured batches after proper review of Batch Manufacturing Record and Analytical records.
• Implementation of document retention policies to retain Master Documents, Validation documents as well as filled documents.
• Providing various declarations / statements as per customer requirement.
• Filling Vendor Questionnaire appropriately and submit to customers.
• Reviewing and Approving quality agreements.

ii) Quality Management System:

• Implementation and maintaining of cGMP in all areas such as manufacturing, testing, warehousing, releasing and dispatches etc.
• Handling market complaints, preparing investigation reports and taking appropriate corrective and preventive actions.
• Conducting Product Quality Review (PQR) to ensure consistency of process.
• Implementation of deviation handling system to investigate, review and approve deviations happened during testing, manufacturing warehousing etc.
• Implementation of change control system to initiate changes, review and approval of changes before implementation. Evaluation and closure of changes with conclusion. Notification of changes to customers and regulatory authorities.
• Implement Out Of Specifications (OOS) investigations procedure. Conducting investigations and CAPA implementation.
• Implement Product recall and Mock recall procedures and maintain appropriate records.
• Making sure that, rejected and returned goods are handled as per procedure.
• Making sure that Corrective actions and preventive actions taken are adequate.
• Taking QA rounds in warehouse, manufacturing and testing zone and ensure compliance of GMP in day today activities.
• Performing risk assessment studies and maintaining record.

iii) Audit and compliance:

• Company presentation to customer and regulatory auditors.
• Conducting service providers site audit and make them approved.
• Handling Regulatory as well as Customer audits as per plan and satisfactory closeout for the observations if any.
• Conducting internal audits (self-inspection) in all departments as per plan and improving performance and growth of organization.
• Conducting site audits of key material suppliers, service providers and maintaining records.
• Third party manufacturing sites audit preparation as per requirement.

iv) Qualification and Validation:

• Making sure that all instruments and equipments are properly qualified and related documents are available and approved.
• Making sure that all major utilities water system, HVAC, compressed air etc. are qualified and records are available and approved.
• Making sure that manufacturing procedures, cleaning procedures and analytical procedures are validated and records are available and approved.

v) Training

• Making sure that training procedure is appropriately designed and as per that training programs are planned and conducted to all employees.
• Conducting cGMP training sessions in all areas and update employee knowledge regularly.
• Making sure that all analysts are qualified to perform analysis.

vi) Supplier Development and Service Provider Approval

• Performing Supplier development, Qualification, evaluation and re-evaluation.
• Conducting cGMP audits to key material suppliers, contract testing laboratories and based on visual inspection and audit compliance report approving them.
• Making sure that all service provider agreements are in place.

vii) cGMP Implementation:

• Implementation of Quality Management System in Pharma industry.
• Initiated and developed Quality Control Laboratory System and related documentation.
• Initiated and developed Quality Assurance system and related documentation.

viii) Manpower handling and work management

• Capable of handling of Quality unit comprising of 37 members.

Benefits Experience to implement USFDA & EDQMIf interested please mail to nayna.k@randstad.inClient Introduction One of the growing Indian Pharma Companyskillsquality, QA, QC, APIqualification

• Implementation of cGMP in areas Development, Manufacturing, Testing, Warehousing, Releasing, Distribution of APIs.
• Played vital role in regulatory audits USFDA, EU GMP, ANVISA, KFDA, COFEPRIS and WHO GMP and made successful.
• Handled ISO certification
• Handled manufacturing project from process development to commercial manufacturing scale and made successful.
• Well versed with the set up of Quality Control laboratory and handled QC release of all API and its intermediates.

,

Keyskills :
organizationsystemagreementsisomajorsalesmanagementmarketingcapacompliancequalitycontrolcertificationsuppliersbudevelopmentbusiness