AGM/DGM Head-Quality Assurance | Wockhardt | Aurangabad

Job Description

AGM/DGM Head-Quality Assurance from Biosimilar Industry

Roles and Responsibilities:

• Responsible for Quality Assurance department activities for the manufacture of high-quality medicinal products by adhering to international standards and continuous improvements with a focus on processes, personnel, and environmental safety.
• Hand-on experience in regulatory inspection especially US-FDA, EMA, PMDA, MHRA, ANVISA, SAHPR (formal MCC), GCC, and various different regulatory agencies.
• Hands-on experience in handling DS & DP batch release through SAP with proper GMP control at various departments like Manufacturing, Quality Control, and Document Management. Experience in Drug Product Manufacturing, Pharma Engineering, and medical devices is an added advantage.
• Management of overall batch release from manufacturing and testing; provide regular updates to supply chain management to ensure smooth batch release; provide support R&D for new programs; ensure compliance through harmonization of procedures and QAMS related actions including appropriate evaluation of Change Control, Deviation, OOS, OOT, etc.
• Ensure required CQA procedures are adopted and implemented at the Biotech site with proper evaluation and training.
• Ensure implementation of CAPA and updated GMP guidelines.

• Ensure the effectiveness of quality management systems at the Biotech site.
• Implementation and adherence to manufacturing and laboratory safety.
• Adherence to current Good Laboratory Practices and current Good Manufacturing Practices.
• Budgeting and identification of appropriate manpower and hiring; ensuring the QA section is adequately resourced with trained personnel.
• Ensure the responsibilities and authority of employees are adequately defined.
• Routine and Periodic visits in Manufacturing, QC, and Warehouse to ensure GMP procedures are followed including proper training to cross-functional teams.
• Problem-solving capability with the involvement of a cross-functional team.
• Good networking with internal and external teams, self-motivated, and respect for the entire team.
• To identify new procedures along with cross-functional teams including gap assessment in the existing quality system.
• Responsible for approving various quality system-related documents like SOPs, protocols, batch manufacturing records, testing records, reports, etc.
• Routine and Periodic Management review meetings and identify opportunities for continual improvement of Products, Systems, and Processes.
• Review standard operating procedures, instrument/equipment operating procedures, general methods, vendor qualification, contract manufacturing and contract testing laboratory-related documents, and Technology transfer documents and ensure qualified equipment, validated methods and qualified facilities are used for manufacturing and testing.
• Capability to take decisions on routine activities like OOT, OOS, Change Control, and deviation investigations and ensure adequate CAPA is implemented.
• Lead and interact with internal and external auditors for internal/customer/regulatory audits.
• Appropriate review in the investigation of customer complaints, and recall of the product from an internal or external customer.
• Review and provide support for LIMS implementation and its management.
• Interact with production, R&D, regulatory department, and other stakeholders for improvement/ revision of procedures or specifications; interact with Alliance partners/customers for addressing information requests and other requirements.
• Interact with the EHS department for lab/personnel safety and ensure effective implementation of the EHS management system in the organization.
• Provide goals for the team and conduct half-yearly and annual performance appraisals for the team
• Participate in monthly QA staff meetings to provide updates on QA activities (e.g., achievements, issues, milestones)
• Hands-on experience with regulatory inspections from USFDA, EMA, PMDA, TGA, ANVISA, MHRA, etc.
• Working experience with online Quality Management Systems like QAMS, L2LMS, SAP, LIMS, etc.
• Good understanding of biotech product manufacturing, testing, and related system.
• Good understanding of Process validation, Cleaning validation, and BLA-supporting studies.
• In-depth knowledge of the preparation/review of documents like SOPs, Quality Systems (OOS, OOT, Deviation, Change Control, Risk Management, various GMP reports, Method Validation reports, Specification, Test Method, Test Data Sheet, Tech transfer reports, Sample Management, etc.

Desired Candidate Profile

• Hands-on experience with regulatory inspections from USFDA, EMA, PMDA, TGA, ANVISA, MHRA, etc.
• Minimum 10 years of experience in the Biotech Industry with hands-on experience.
• Working experience with online Quality Management Systems like QAMS, L2LMS, SAP, LIMS, etc.
• Good understanding of biotech product manufacturing, testing, and related system.
• Good understanding of Process validation, Cleaning validation, and BLA-supporting studies.