IPQA Executive

JOB DESCRIPTION

Job Title: IPQA Executive 

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
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role:

• Ensure IPQA activities at shop floor during manufacturing
• Line Clearance during Batch change over and Product Change over.
• In process Product Quality Monitoring.
• Dispatch inspection and Clearance.
• Review of Master, Executed Batch Manufacturing Records, Packing and Dispatch records.
• Preparation, review and revision of QA Procedures.
• Any other responsibility as assigned by Head QA based on knowledge, Experience and learning.

Role Accountabilities

• Conducting cGMP inspections across the manufacturing plant and supporting area.
• Issuance of Batch Numbers, Batch Manufacturing Records, Packing and Dispatch records.
• Review of Master, Executed Batch Manufacturing Records, Packing and Dispatch records.
• Preparation and review of standard operating procedures.
• Review of equipment qualification documents.
• In process Product Quality Monitoring.
• Dispatch inspection and Clearance.
• Monitoring of dispensing and other relevant warehouse activity
• Inspection of Raw material (RM), packing material (PM) and manufacturing consumables for any damage/discrepancy possible during receipt, storage, dispensing and handling of these materials in Warehouse.
• Issuance of Format numbers, Log books, Operating Procedures.
• To ensure implementation and propagation of all EHSS norms so as to create safe working environment.

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 to 6 years

Technical Skills and Capabilities:

• Candidate should have adequate knowledge and experience in IPQA shop floor activities in Injectable facility.
• 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 tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should able to work in team and flexible for working in shifts.
• Should be a focused employee.

Education:

M. Pharm with minimum 3 -6 years of working experience with Injectable facility.

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.