Takeda Hiring Sr. Executive, QA Post graduate degree in Pharmacy or Science Apply Now
Takeda Hiring Sr. Executive, QA Post graduate degree in Pharmacy or Science Apply Now
Job Description
Objective
- Lead overall Quality Activities including In-process Quality for Takeda in India to ensure its compliance to Current Good Manufacturing Practices (cGMP) as per Schedule M of Drugs and Cosmetics Act and Takeda’s global requirements for Redressing Activities (Stamping, Stickering and Overprinting) and release of redressed Takeda products
- Lead activities to develop, implement and maintain a systematic, effective and efficient local Quality Management System (QMS) as per Schedule M of Drugs and Cosmetics Act and Takeda’s global requirements for Redressing Activities.
- To resolve quality issues pertaining to redressed products to support the continuous supply of Takeda products in India.
Key Responsibilities
- Implementation ,sustainance and governance of Quality Assurance Standards, processes, controls and cGMP in Redressing unit.
- To ensure issuance of BPR.
- To ensure that training for SOP’s, cGMP and On the Job training are imparted to Redressing unit staff.
- To ensure Redressing activities are carried out as per approved Batch Packing Record (BPR).
- To perform IPQC during the Redressing activity.
- Review of Batch Packing Record and Batch Release.
- Maintaining proper documentation and reports.
- Verification of damaged stocks.
- Verification and approvals of Stamp on packing line.
- Verification and approvals of stickers and labels.
- Verification of logbooks.
- Verification of the cleanliness and pest control activity in Redressing unit.
- Verification of the temperature of Packing lines & storage areas of Redressing unit.
- To monitor control sample withdrawal, storage and destruction if required.
- Verification of Calibration and Validation schedule.
- Verification of Preventive Maintenance of facility.
- Qualification of Suppliers and Overall Supplier Management Activities.
- To communicate with customer for any matter related to Redressing Product if required.
- Verification of calibration and validation documents of the Redressing Facility. •
Lead activities for Takeda in India to develop, implement and maintain a systematic, effective and efficient local Quality Management System (QMS) as ensure its compliance to Current Good Manufacturing Practices (cGMP) as per Schedule M of Drugs and Cosmetics Act and Takeda’s global requirements for Redressing Activities.
- The QMS includes but are not limited to documentation creation like Site Master File, Quality Manual, document maintenance & control, Maintenance of logs, SOP writing, personnel training management, Redressed product release, product sample management, product complaint handling, Change Control, Deviation, CAPA ,Gap Assessments.
- Handling of Self Inspections, Takeda Internal Audits and Regulatory Audits by Indian Authorities or any other inspections /Audits.
- Handling of electronic QMS systems like TrackWise, Training systems and electronic documentation management systems.
- Provide support to ensure all KPIs for local quality operation for Takeda India meet the established requirements.
- To execute any other assignment allocated by Head Quality.
Mandatory Requirement
- Minimum 2 years practical experience in the testing of drug products especially blood products and possess :
- Post graduate degree in Pharmacy or Science(Chemistry/Microbiology/Biochemistry) or
- Post graduate degree in Medicine – MD (Microbiology/Pathology/Biochemistry) from a recognized University or Institution.
- Preferably Approved as a Technical Analyst by State’s FDA Authority. Minimum 5-6 years’ experience in Pharmaceutical Company in quality function with GMP manufacturing plant environment of Blood Products manufacturing and sterile Pharmaceuticals
- Good knowledge and experience in working on the development, implementation and maintenance of a Quality Management System compliant to local India regulatory requirements on Good Manufacturing Practices (cGMP) and Good Distribution Practice (GDP) and Drugs and Cosmetics Act, Schedule M and WHO guidelines.
- Good knowledge and experience on managing/performing quality operation activities and the regulatory requirements for the manufacturing, product release, storage and distribution of pharmaceutical products (including biologics and cold chain).
- Sound knowledge and experience in working with cGMP and quality management system elements and guidelines (e.g., PIC/s, ICH, ISO9001 or ISO 13485) and cold chain product repackaging.
- Experience in managing supplier audits, internal audits, regulatory authority inspections.
- Ability to work independently and identify compliance risks and escalate when necessary Good sense of urgency and strong follow up Scientific Knowledge
- Ability to manage complex projects and timelines in a matrix team environment.
- Demonstrated interpersonal skills including strong negotiation skills.
- Excellent teamwork and coordination skills