Stallion Laboratories- Hiring QA Head, Production Head, QC Head
Stallion Laboratories incorporated in 1988 as an integrated private sector Pharmaceutical Formulation Manufacturer, has acquired an unmatched record of managing niche product in formulations with a WHO GMP approved production facility and GLP qualified stringent quality control. The path of success lies in its belief of creativity and no negotiation with the quality of work.
Following opportunities for our Unit-2 (US-FDA approved) for very passionate, dynamic and strong leadership roles in different areas (Minimum 10 US-FDA audit faced).
• To lead and manage the strategic and operational performance of Development Quality, contributing to the successful delivery of the business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to Regulatory and Quality compliance including Company standards, local and international regulations to achieve success in development projects and ensure the efficient and effective day-to-day running.
• Responsible for to managing and facilitating the QMS implementation, standardization and adherence of site manufacturing in accordance to cGMP, ISO, CFR 820 applicable regulatory requirements as well as Quality Manual requirements including E- Complianceand Laboratory Compliance
• Develop, implement and maintain the self-inspection and external (e.g. supplier) audit program and conduct the self-inspection and supplier audits as per an established schedule ensuring all quality systems are reviewed and completed
• To manage and lead the projects within the FDA regulated industries on Documentation, Systems Set Up and Enhancements, Quality Control, Quality Assurance, Regulatory-N DA/AN DA Preparations and Reviews, Auditing, Method and Process Validation, Calibrations, Workflow Analysis and GMP training.
• Review audit readiness strategy and oversee audit preparedness for regulatory bodies inspections by managing field CAPA’s, any regulatory actions, follow ups and assisting in production problem resolution
• Improve process associated with the quality system to ensure review on a periodic basis continually increasing compliance as well as staying with current or ahead on industry trends
• Ensure Complaint Handling, Non-conformance and OOS investigations are carried out as per the procedures
• Manage Supplier Quality Assurance and Supplier Quality Development to include supplier qualifications, action plans, audits, performance monitoring, and assisting key suppliers towards industrial standards of excellence
• Handle floor auditing, batch record review, AQL inspections, and oversee Quality management functions in Manufacturing, Inspection, Packaging and Warehousing activities
• Responsible for approving SOP’s, Batch Records Protocols and other cCMP documents and ensuring adherence to applicable regulatory requirements.
• Responsible for Continuous Process Verification using statistical tools. To actively participate in regulatory inspection readiness program and Act as spokesperson during regulatory inspections for assigned responsibilities.
• Applied coaching techniques to support team members in improving performance. To assist all stakeholders on site in implementing Quality Systems complying with applicable regulations.
Skills : Quality Management Systems and Operational Quality, Quality Assurance, Process Improvement, Team Building, Vendor Management, Validation Compliance
• Extensive experience in spearheading the production activities involving production planning, resources planning and its utilization, management of manpower resources, developing and implementing SOP’s and planning for Process validation and TechnologyTransfer and ensuring superior productivity by streamlining key processes and achieving operational improvement. Coaches sub-ordinates to build capabilities, skills and technical knowledge. Ensures adequate resources are available to meet current and projected production volumes.
• Strong problem-solving capabilities derived from extensive equipment knowledge. Strong leadership track-record with high levels of ownership, accountability and technical competency at all levels within the organization.
• Responsibilities include handing and monitoring of Warehouse, Manufacturing and Packaging Activity.
• Planning the monthly production of manufacturing and packing and To deliver commercial goods as per dispatch schedule and commitment.
• Ensure to coordinate with internal suppliers and customers.
• Ensure to prepare the SOPsforthecriticaloperationsand equipment.
• Ensure to aim to achieve zero deviation and 100% utilization of the available resources (manpower, machineries and budget). Ensure a control on consumption of consumables and stationaries.
• Has extensive experience in managing cGMP compliance needs, deployment of Quality Management Systems and relations with external auditors and regulators and USFDA audit exposure.
• Ensure to aim to achieve zero deviation and 100% utilization of the available resources (manpower, machineries and budget). Handling of Change/Deviation and implement corrective action.
Skills : Team Management • CMP • Formulation • TechnologyTransfer • Validation • QMS • Incident Management • Corrective and Preventive Action (CAPA) • Change Control • Deviation Management • Qualifications • Project Planning • Production Planning • Standard Operating Procedure (SOP) • Materials Management
• Leading a team of QC members and having extensive experience in Quality Control Functions, Finished product, process Validation, stability and documentation.
• Demonstrated excellence in leadership skills, strong analytical work and documentation as per the pharmaceutical industry regulations.
• Deft in disseminating information from regulators and external industry bodies.
• Adept in handling development & Submission of compliant/high quality documentation for audit compliance.
• Skilled in steering maintenance & calibrations process & validations of all analytical instruments.
• Displayed prowess in spearheading activities related to stability, raw materials & lab supporting and performing regulatory & customer audits.
• Maintaining all validations documents regarding Environmental Monitoring, WFI testing for inspection purpose and as per requirements.
• Monitoring regulatory developments by establishing and maintaining good relations with relevant authorities.
• Preparing specifications & SOP’s and undertaking analytical method validation.
• Proficient in Quality Management Systems and Assuring and releasing of Exhibit Batches and commercial batches for regulated markets. Excellent written and oral communication skills to communicate effectively with cross functional teams.
Skills : Laboratory compliance, Data Integrity, Regulatory requirements, Audit management, Investigations, CAPA, Impact Assessment, Training, Global projects, Validation (Drug Manufacture) • Project Management • Standard Operating Procedure (SOP) • Good Manufacturing Practice (GMP) • Quality Control • Corrective and Preventive Action (CAPA) • Analytical Skills • Business Process • Auditing • Requirements Analysis
Salary is no bar for potential leaders
Job Location : 8th Floor, Devpath, B/H Super Mall, Near Lai Bunglow, Navrangpura, Ahmedabad, Gujarat 380009
Please send your Cv on : firstname.lastname@example.org and do specify subject line with Dept. Name.
Last Date : 30th December, 2023