QMS Project Reviewer

Job Title: QMS Project Reviewer

Job Location: Syngene International Limited, Bengaluru

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:

This is an exciting opportunity to play a role in drug substance development and manufacturing of Syngene. The role will provide exposure to handling clients across the globe, interaction with cross-functional departments and activities involved from product introduction to discontinuation. It provides an opportunity to learn different aspects of product development to commercial manufacturing.

Role Accountabilities:

Follow GMP, GDP, and GLP procedures as applicable, while performing the assigned task. Create/ revise/ review of procedures (like SOP, protocols, calibration schedule, and other related documents as applicable. ). Review and approval of Master BMR and PDR and its compliance. Review of TTD related to Late phase and commercial. Responsible for issuance and control of BMRs, PDRs, SOPs, EOPs and ECCs. Verify the product details, batch no. , quantity, label, purchase order, RM issue slip, CoA, weights, packing and dispatch record, packing area (not limited to) and provide clearance to dispatch activity. Assessment of SOP vs guidelines for any gaps and taking appropriate actions. Investigate, review of investigation with respect to OOS/OOT and involve in the identification of root cause and to propose the CAPA for identified root cause. Preparation and review of QMS Trends (Deviation, LIR, OOS, OOT, Change control & Complaints). Handling of returned products and product recall.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence


• Integrity


• Professionalism

Specific requirements for this role

1. Experience


2. Demonstrated Capability


3. Education

Experience

3 - 6 years into Project related QMS activities (Change control, Deviations, CAPA, OOS, LIRs)

Must have handled clients

Expertise in review of Master Batch Record, Batch Record and Analytical Documents

Knowledge on Good Documentation and laboratory practices

Good coordination among CFTs

Skills and Capabilities

Expertise in handling QMS Activities

Good knowledge about project related activities

Client handling experience

Master Batch Record, Batch Record and Analytical Document Review skills

Specification and Method of analysis review

Good communication skills

Education

MSc. Chemistry

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.