Syngene QA Pharma Job – Apply For Executive Job
About Syngene :
Syngene (www.syngeneintl.com) is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
Job Title: Executive
Job Location: Bangalore
Job Grade: 9-I
Mandatory expectation for all roles as per Syngene safety guidelines
- Overall adherence to safe practices and procedures of oneself and the teams aligned
- Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
- Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
- Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
- Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
- Compliance to Syngene’ s quality standards at all times
Core Purpose of the Role / Role Accountabilities :
- Quality Management System (QMS): Responsible for the QMS of departments’ related to Phase I, BA / BE – Human Pharmacology Unit, Phase II to Phase IV Clinical Trials- Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Central Laboratory, Bioanalytical Research Laboratory; and other support departments of Syngene Clinical Development.
- Standard Operating Procedures’ (SOPs’): Preparation and revision of SOPs’ relevant to their area; review of SOPs’ from relevant departments; issue of SOPs’, forms and log books to relevant departments; retrieval of obsolete SOPs’; control of master (original) SOPs’ – current as well as obsolete SOPs’. Any other responsibilities as indicated in relevant SOPs. Responsible for performing all the activities as EDMS coordinator.
- Change Control/ Deviation: Initiate relevant QMS item, review of the QMS item taken by the departments, follow up of the same for closure.
- Record control – ensure that all records are written legible. Control and maintain records in the QA department.
- Share best practices and ideas with fellow QA personnel.
- Analyze the root-cause for non-compliance / deviations; analyze trends observed (if any) and advice on resolving issues.
- Suggest improvement potential and best practices.
- Communicate lessons learnt to fellow QA personnel and apply the best practices across departments.
- Sponsor audits: Participate in Sponsor audits by preparing for the audit – liaising with the relevant department for preparation. Interact with Sponsor auditors – accompany and answer queries during the audit. Prepare and review corrective and preventive action plan and follow-up on the implementation of the same.
- Regulatory inspections: Participate in Regulatory inspections by preparing- liaising with the relevant department for the preparation; review documents, conduct mock-audits, guide personnel. Interact with Regulatory inspectors – accompany and answer queries during the audit. Prepare and review corrective and preventive action plan and follow-up on the implementation of the same.
- Training: Responsible for performing all the activities as Training coordinator/ LMS coordinator Identify training needs from audit experience and communicate to Head, QA and / or HR department. Inculcate the habit of self-development and participate in group discussions, seminars, workshops, etc. Drive education of document control across the organization. Train personnel in relevant guidelines and regulations.
- Management Review: Participate in management review meetings by preparing relevant presentations, suggesting best practices / improvements and implement the follow-up action indicated during the review.
- Following are the responsibilities related to Archivist at Syngene International Limited-Clinical Development (In house archives/ Third-party archives)
- Ensure all activities related to Archives performed as per SOPs like Temperature & Humidity monitoring, Cleaning of Archival archives, any activity related to EHSS or Engineering & Maintenance.
- Ensure timely archival, retrieval and re-archival of documents (In-house as well as Third- party).
- Perform Mock-Recall for Third-party archives as per SOP.
- Receiving documents for archival from respective departmental study personnel and verify whether all documents are appropriately filed, labeled and numbered.
- Maintain all the Archives related logbooks.
- Communicating with Third-party archives for issues related to archives.
- To prepare & maintain documents related to Archives.
All employees will consistently demonstrate alignment with our core values
Specific requirements for this role
- Experience- 2-3 Years of experience
- Demonstrated Capability: Good learner and good at logical thinking
- Education: B.Sc./ M.Sc./ B Pharm
Skills and Capabilities: Good at MS excel
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