AQA reviewer

                                                                                                                    JOB DESCRIPTION

 Designation: AQA Reviewer

Job Location: Bangalore

Department: Analytical Quality Assurance

About Syngene

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.

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

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

 Job Purpose: To review the data & reports generated from GMP Laboratory (Stability) and to monitor the GMP Lab compliance.

 Key responsibilities:

1)  Online Sequence & Document review in HPLC, GC, KF, PXRD,  ICPMS, LCMS & other all analytical instruments.  (CD & FC – Intermediate, FP & Stability)

2)  Offline Raw Data review in ELN (CD & FC – IPQC, Intermediate, FP & Stability) and release of IPQC TI sheets in 24/7 

3)  Daily verification data review, PM reports and Lamp intensity report review in ELN.

4)  Compiled Report review (CD & FC – IPQC, Intermediate, FP & Stability).

5)  Calibration sequence, data review of HPLC (S17) and release of instrument. Raw material data review and release in LIMS & SAP.

6)  Reconciliation of EDMS issued prints (formats).

7)  Audit trial review of Standalone systems and chromeleon application.

8)  Monthly Date & Time verification of approximately 20 standalone instruments.

9) Review of analytical raw data generated by analyst, protocols/ reports pertaining to the section as per the standard operating procedure and specification.

10) Ensuring, verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP.

11) Review of Outsourced analytical report.

12) Review of logbooks with respect to all activity performed in the lab.

13) Responsible for taking any other job allocated by Department Head / Department In charge.

14) Review of technical data in analytical document viz. Calculations, Chromatograms, method parameters, integration, logbook entries, WS/RS and Column usage records, method parameters, reconciliation, vendor COA and other technical data in analytical document.

15) Reviewer shall ensure the documents physically for availability of all the pages of ODS and supporting documents.

16) Review the documents for completeness, compliance to Good documentation practices, test results against specification limits or acceptance criteria as mentioned in protocol and reconciliation of forms issued as applicable

17) In case of any discrepancy, immediately notify to the reporting manager or his designee or Head or designee GMP Analytical Laboratory.

18) Ensuring of conducting regular GMP rounds at Quality Control Laboratory.

Educational Qualification: M.Sc. Chemistry or Analytical or equivalent

Technical/functional Skills:

The candidate should possess good communication, leadership and technical skills in Laboratory instruments like HPLC, GC,GCMS, LCMS, PXRD,KF etc., . He / she should have working knowledge in quality, conducting investigations and quality management systems. He / she should have experience in review of data generated from QC team of QA professional.

 Experience: 4 to 8 years

 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.