AQA Microbiology Reviewer

JOB DESCRIPTION

Job Title: AQA Microbiology Reviewer

Job Location: Bangalore

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

Core Purpose of the Role :

• Microbiology laboratory QMS review including Deviation, OOS, OOT, LIR, CAPA, Change controls.
• Review of audit observation responses
• Review / Approval of Microbial Method Validation, Method verifications
• Review / Approval of analytical data generated by Microbiology
• Microbiology lab compliance verification
• Media and culture qualifications data approval
• Approval of data in ELN and LIMS
• Issuance of logbooks
• Document archival
• Audit trail review of Microbiology instruments

Role Accountabilities

• Responsible for Analytical QA activities related to Quality control Microbiology and QC Biologics.
• Issuance of logbook and archival.
• Issuance of documents, logbooks, forms and archival of related documents
• Review and approval of trends, protocol and reports related to to EM, water and samples.
• Preparation and review of QMS trends.
• Microbiology laboratory QMS review including Deviation, OOS, OOT, LIR, CAPA, Change controls.
• Participate in investigations
• Review of audit trail.
• Conduct audit and regular GMP rounds
• Review and approval of SOP, EOP, IOP, specification, CSV protocols and qualifications documents.
• Audit trail review of Microbiology instruments as per planner
• Interaction with clients
• Review and approval of the documents in adequacy with respect to principle of ALCOA+
• Review and approval of EAM, IT and relevant cross function team documents.
• Review and approval of risk assessment documents.
• Review and closure of Laboratory incident reports.
• Ready to work in shifts and supervising the shift analyst activities
• Well versed with LIMS and electronic documents execution and review.
• Undertake other responsibilities related to AQA Microbiology as per requirement.
• Follow the required EHSS policies and Good hygiene practice.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience : 9 – 12 years

2. Demonstrated Capability :

3. Education : M.Sc. Microbiology, Biotechnology.

Skills and Capabilities

• 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 deadlines and prioritize workloads
• Ability to develop new ideas and creative solutions
• Should be able to work in team and be flexible working in shifts
• Should be a focused employee
• Good documentation capability

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.