Title:  Head QA

Designation: Sr. Manager QA
Job Location: Mangalore
Department: Quality Assurance – GMP – Chem Dev.

 AboutSyngene
Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Purpose:
Head – Quality Assurance

          Job Description:

• Responsible for providing Quality Assurance support for executing GMP manufacturing activities at the Mangalore manufacturing facilities, including involvement in all quality-related matters.
• Prepare, revise, and issue the quality manual and site master file.
• Coordinate and verify corrective and preventive actions taken against non-conformances observed during audits.
• Plan and coordinate review meetings to ensure the continuing suitability, adequacy, and effectiveness of the quality system.
• Well-versed in all national and international regulatory agency requirements such as ICH, USFDA, WHO Geneva, PMDA Japan, EDQM, MHRA, TGA, etc., for API manufacturing.
• Approval of all procedures impacting the quality of intermediates and APIs.
• Responsible for evaluation and approval of vendors/subcontractors and service providers of small molecule drug substances, followed by qualification of testing laboratories.
• Review and approval of Validation Master Plan. Monitor revalidation/qualification strategy and ensure VMP complies with regulatory requirements and Syngene's internal practices.
• Approval of URS, impact assessment, protocols, and reports related to qualification and validations of facility/area, equipment, and utilities in manufacturing facility, QC, and warehouse.
• Ensure execution of DQ, IQ, OQ, and PQ activities for new facility/product/process/testing equipment with proper documentation.
• Ensure QA validation oversight, assessing risk/impact on validated state during any deviations related to facility, clean utilities, and equipment through change control.
• Ensure implementation and usage of electronic QMS tools such as Learning Management System (LMS), Laboratory Information Management System (LIMS), Trackwise, Document Management System (DMS).
• Ensure effective systems are used for maintaining and calibrating critical equipment.

• Ensure QA oversight during initial and periodic Qualification of Heating Ventilation and Air Conditioning (HVAC) systems, Laminar Air Flow (LAF) systems, Temperature and RH mapping of identified areas and equipment, in coordination with user, engineering team, and external parties if required.
• Establish systems for release or rejection of raw materials, intermediates, finished products, packaging, and labeling materials.
• Approval of Master Batch Manufacturing Records, Master Packing and Dispatch Records, Specifications, Standard Operating Procedures (SOPs), annexures, Validation documents, Qualification documents, and other quality documents.
• Review and approval of Process, Cleaning, Analytical Method validation/transfer, Computerized system validation, Hold time, Spreadsheets, and all other validation/qualification protocols and reports, including raw data.
• Approval of changes that potentially impact intermediate or API quality.
• Approval of customer complaint investigations, resolution of complaints, approval of Corrective and Preventive Actions (CAPAs), and ensuring their implementation and effectiveness.
• Review and approval of Annual Product Quality Reports.
• Ensure Quality Control (Chemical and Microbiological) Specifications, SOPs, Instrument Operating Procedures (IOPs), and Standard Test Procedures (STPs) are reviewed and approved for Raw Materials, In-process, Finished Product, and Stability studies.
• Review and approval of analytical method validations.
• Monitoring and controlling stability programs, Data Integrity compliance, Out of Specification (OOS), Out of Trend (OOT) investigations, Laboratory Incidents, and day-to-day compliance of QC with specific quality guidelines.
• Handling customer and regulatory inspections.
• Ensure computerized systems comply with relevant SOPs and regulatory guidelines.
• Ensure execution of process validation and cleaning validation activities.
• Ensure availability of optimum resources and operate the department within the specified budget. Support Department Head in preparing the annual budget.

• Key Responsibilities:
  Establishing and maintaining a robust QMS in accordance with regulatory requirements (e.g., ICH, FDA, EMA).
• Implementing policies, procedures, and standards to ensure consistent quality across manufacturing processes.
• Ensuring API manufacturing processes comply with relevant regulatory guidelines and standards.
• Being responsible for regulatory inspections and audits, and managing responses and corrective actions.
• Ensuring compliance with data integrity policy and identifying the cause of non-compliance.
• Conducting risk assessments related to manufacturing processes, raw materials, and product quality. Implementing risk mitigation strategies to minimize potential quality issues.
• Managing change control processes for modifications to facilities, equipment, processes, and procedures. Evaluating potential impacts on product quality and regulatory compliance.
• Overseeing validation activities for equipment, processes, and cleaning procedures. Ensuring qualification of suppliers and contractors to maintain quality standards.
• Providing training and development programs for QA personnel to ensure understanding of regulatory requirements and quality standards. Promoting a culture of quality and compliance throughout the organization.
• Monitoring quality metrics and performance indicators to identify opportunities for improvement. Implementing continuous improvement initiatives to enhance quality systems and processes.
• Performing self-inspections and ensuring manufacturing operations are maintained in an audit-ready state at all times (ATAR).
• Ensuring the archival of documents and third-party archival activities within SLA and ensuring compliance from the respective departments.
• Adhering to safe practices and procedures personally and ensuring teams are aligned with safety standards.

Educational Qualification:  M.Sc. (Chemistry), B Pharma/M Pharma or any other equivalent university degree.

Technical/functional Skills:
• Good communication skills and experience in API industry.

Experience: 15 to 20 Years

Behavioural Skills:
•            Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and      persuasive ability in a team.

•            Good speaking-listening-writing skills, attention to details, proactive self-starter.

•            Ability to work successfully in a dynamic, ambiguous environment.

•            Ability to meet tight deadlines and prioritize workloads.

•            Ability to develop new ideas and creative solutions.

•            Should be able to work in team and flexible for working in shifts.

•            Should be a focused employee.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.