Job Description

Designation: Manager
Job Location: Bangalore
Department: Quality Assurance - Small MoleculeAboutSyngene
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:
Team lead - IPQA:

• Ensure compliance with GMP, GDP, and GLP procedures and identify the cause of non- compliance.

• Ensure compliance with Data integrity policy and identify the cause of non-compliance.

• Ensure compliance with the safety policy. procedures, and stated requirements and identify the cause of non-compliance.

• Ensure compliance with SOPs and approved instructions and identify the cause of non- compliance.

• Ensure the training and qualification of supervisors working in respective area.

• Review and approval of SOPs, protocols, schedules and other related documents as
• applicable.

• Review and approval of Master BMR and its compliance.

• Ensure review of Executed BMR within SLA and ensure the compliance from the respective department.

• Ensure the issuance of logbooks and formats with in SLA .

• Ensure the Dispatch activity and train the associates.

• Ensure the line clearance activity and train the associates.

• Implement improvement ideas and appropriate measures to reduce Non conformance and increase productivity.

• Provide appropriate and timely responses to audit observations.

• Provide timely compliance to the audit observation and track the proposed CAPA

• Perform self-inspection and ensure manufacturing operations are maintained in an all- time audit-ready (ATAR).

• Ensure the identified gaps having the adequate control measures and appropriate actions has been taken.

• Ensure the vendor Qualification and approve of vendor upon complies with procedure. Track the validity of approved vendor and initiate the periodic qualification.

• Review of Quality agreement as applicable. Maintain the list of Quality agreement.

• Review of Client Questionnaire and ensure the confidentiality of document\'

.

• Review of investigation, Categorize the Deviation and provide inputs in the identification of root cause.

• Propose, Review, approve and closure of CAPA. Track the CAPA for timely implement.

• Review change control. Approval of extension if change control unable to close within the specified timeline.

• Review of investigation, Categorize the OOS/OOT and provide inputs in the identification of root cause and to propose the CAPA for identified CAPA..

• Review of investigation, provide inputs in the identification of root cause and to propose
• the CAPA for identified CAPA.

• Ensure review of specification within SLA and ensure the compliance from the respective department.

• Ensure the execution of process validation and cleaning validation activities.

• Ensure CSV related documents and ensure the compliance from the respective department.

• Ensure review of analytical reports within SLA and ensure the compliance from the respective department.

• Review the routine and periodic audit trail and the compliance from the respective department. ...

• Ensure the archival of document and third party archival activity within SLA and ensure the compliance from the respective department.

• Ensure availability of optimum resources and operate the department within the specified budget.Support Department Head in preparing annual budget.

• Review of Management Information system reports.

• Communicate promptly and effectively with the clients and CFT members.

• Ensure training completion before startup of assigned activities.

Key Responsibilities:
1.Ensure compliance with GMP, GDP, and GLP procedures and identify the cause of non- compliance.2. Ensure compliance with Data integrity policy and identify the cause of non-compliance.3. Ensure compliance with SOPs and approved instructions and identify the cause of non- compliance4. Ensure review of Executed BMR within SLA and ensure the compliance from the respective department.5. Provide appropriate and timely responses to audit observations.6. Perform self-inspection and ensure manufacturing operations are maintained in an all- time audit-ready (ATAR).7. Ensure the archival of document and third party archival activity within SLA and ensure the compliance from the respective department.8. Overall adherence to safe practices and procedures of oneself and the teams alignedEducational Qualification: M.ScTechnical/functional Skills:

• Good communication skills and experience in API industry.

Experience: 15+ YearsBehavioral 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 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.

Syngene International