Syngene Career Opportunities: QA Reviewer Position Apply Now

Job description

Job title: Senior Executive

Job location: Bangalore

Job grade: 9-II

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. At syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and sops, in letter and spirit

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

• Hold self and their teams accountable for the achievement of safety goals

• Govern and Review safety metrics from time to time

KEY RESPONSIBILITIES:

Preparation of SOP for Quality Assurance and ensuring the timely revision of the same.
Review of SOP, IOP, EOP, GP etc. for Quality departments.
Review and authorized for Approval of blank ODS, issuance of the copy from master ODS for lab execution and reconciliation of analytical package after completion.
Issuance and withdrawal of Logbook, SOP, IOP, EOP, GP etc. and annexures wherever applicable and maintenance of issuance/ withdrawal records.
Monitoring the usage of current approved procedures in all relevant departments.
To ensure compliance with cGMP as laid down in the procedures.
Monitoring changes implemented in compliance to cGMP.
Verification and reconciliation of analytical reports received from Quality Control.
Maintenance, issuance and control of master documents.
Review of Qualification Protocols and Reports (URS/IQ/OQ/PQ/DQ) before and after the completion of activities related to Instrument/Equipment Qualification External/Internal as applicable.
Issuance, evaluation review of CCF and to ensure timely closure of the same.
Deriving (wherever applicable) and monitoring of CAPA implemented for its effectiveness.
Ensuring on-line documentation and timely entry of operations performed in laboratory during testing.
Ensuring adequate identification and segregation of test samples to avoid mix up and cross contamination.
Monitoring revision of specifications and test methods to ensure compliance with statutory and company standards.
Monitoring and ensuring software controls used in the laboratory.
Preparation of trends/data bank of different types of non-conformities.
Monitoring of samples receipt and inception, incubation, labeling, pull out of samples as per schedule and pull out window.
Monitoring of stability study conducted in accordance with the requirement specified in respective SOP.
Monitor the investigation in case of excursion/breakdown of Stability chambers/incubators. Verification of data for temperature and humidity generated from stability chambers/incubators periodically for compliance.
Review of Protocols and Reports for analytical activities.
Review of QMS on trackwise.

JOB PURPOSE (Briefly describe the objectives of the job):

To Review of Analytical documents generated by QC, review of instrument and software qualification documents, to prepare SOPs, Perform trending of all the non-conformities, Handling of QMS using Trackwise and conducting trainings using LMS.

EDUCATIONAL QUALIFICATION: M.Sc/ M.Pharma/B.Pharma/B.tech

WORK EXPERIENCE: 3-7 years in Quality Assurance

TECHNICAL /FUNCTIONAL SKILL:

Should have very good communication skills & technical report writing skills.

Should be familiar with cGMP and ICH guidelines.

Good knowledge on US/EU pharmacopoeias and its recent updates.

Should have exposure to various Regulatory audits

BEHAVIORAL/MANAGERIAL SKILLS:

Good communication, technical report writing skills and E- Mail etiquette.

Basic knowledge on Excel sheet and windows operations.