Manager - Compliance

Job Description

• 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
ROLE PURPOSE: Manufacturing, QC Lab, PRD Lab and Warehouse Key Responsibilities:
• Ensure that failures such as deviations, audit observations are adequately investigated, root cause & CAPA identified and implemented.
• Ensure that quality management system documentation is closed with zero overdue as per timelines mentioned in respective SOPs and CAPAs.
• Responsible for timely completion of all documentation-related activities related to manufacturing and warehouse and ensure compliance with Good Manufacturing Practices and other regulatory requirements.
• Responsible for ensuring manufacturing facility and warehouse is in a state of all-time audit readiness and self-inspections by conducting spot checks.
• Collaborating with a cross-functional team involving Process & Research, Technology Transfer, Delivery, Engineering & Maintenance, Quality control and Quality Assurance for manufacturing and warehouse related activities and concerns.
• Ensure all manufacturing and warehouse equipment are functioning according to GMP requirements. Their qualification and calibration comply as per 21 CFR part 11 compliance requirement, ICH and FDA guidelines.
• Ensure that human errors in the documentation are monitored, reviewed, reduced and controlled within justifiable limits.
• Ensure all manufacturing and warehouse members undergo the required training and their knowledge and skills are updated to perform the duties efficiently.
• Responsible to Interact with the EHSS department for personnel safety.
• Responsible for deploying the right cleaning strategies for equipment cleaning at the manufacturing facility.
• Responsible for recruiting the right personnel to address any gaps related to manufacturing and warehousing.
• Responsible for evaluating regulatory surveillance needs and implementing the SOPs with necessary actions on time to correct non-compliances at manufacturing and warehouse.
• Responsible for writing SOPs, EOPs, Protocols & reports adequately and are complied with fully for each operation related to manufacturing and warehouse to avoid any gap between SOP Vs. Practices.
• Responsible for educating the employees about the Data Integrity policies/procedures and personnel safety and implementing those procedures to avoid any DI or Safety incident at manufacturing and warehouse
Educational Qualification & Experience
• M. Tech (Chemical Engineering/ Biotechnology) / M. Pharma
• 10 to 15 years of Industrial Experience in reputed Pharmaceutical Quality Assurance Department
• Must have experience in leading the investigations and writing investigation reports and process qualification reports related to manufacturing and warehouse with the right-first-time approach.
• Must have experience in preparing and reviewing of process validation, cleaning validation.
• Experience in handling of audits- regulatory, clients, and internal.
• Knowledge in cGMP, ICH, USP and other pharma regulatory guidelines.
• Regular interaction with QA to ensure timely closure of all QMS documents.
• Must have experience in training the team members for GMP activities in Production.
• Must have experience in 21 CFR Part 11 compliance environment and data integrity practices.
• Must have experience in cleaning strategies in multiproduct environment
• Must have expertise in identifying root cause in case of deviations and take appropriate CAPA
• Preparation of capital and revenue budget, manpower projection and recruitment.
• Co-ordination with HR team for the training of employees.
• Experience in evaluating audit trails and alarm management in DCS (distributed control system)
Technical/Functional Skills:
• Familiar with Distributed Control Systems and SCADA
• Good communication skills, both oral and written.
• Hands-on experience writing investigation and process/ cleaning validation reports
Behavioral Skills:
• Effective Communication Skills (Oral communication & presentation skills)
• Ability to influence people
• Adaptability/Flexibility
• Motivational Skills
• Problem-Solving skills
• Influencing skills
• Managing Conflict
• Team Leadership
• Interpersonal Skills
• Personal Integrity
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Keyskills :
pharmaceutical quality assurancequality management systemdata integrity