Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post: QA Compliance Coordinator
Job Description:
Job Purpose:
The job holder has accountability of effective monitoring of compliances (Internal and External) status at the manufacturing unit which are necessary for smooth opearations, and provides periodic feedback to Management and escalates overdue complainces, Compliances includes policies, procedures, regulatory and statutory requirements applicable to ANI Jhagadia site QA.
Job Dimensions:
The position holder accomplishes his job on his / her own there are no direct reportees
• The position holder monitors the compliance requirement of the site QA dept including but not restricted to BIS, FSSA, ISO 9001, 22000, 17025. ICH (International Conference on Hormonisation)
• The job holder has accountability for the effective and efficient monitoring of site wide compliances provides MIS, ensuring all internal and external requirements are adhered to.
Key Responsibilities:
• Conduct gap analysis for corporate policies, sity policies, sop’s and regulatory requirements applicable to site and develop action plan to close the gap and mititgate risk
• Responsible for establishing, managing and implementing Records Management policy, Records Retention and retrival procedures are in place.
• To monitor internal and extenral audit schedules and follow up on action plan,
• Requires to work closely with ANI Division to understand the broader initiatives being driven in respect of compliance requirement and how these impact at a site level
• Developing strong relationships with ‘Curriculum Owners’ at site, namely in EHS and Quality to ensure curricula for all roles have been effectively defined and are subsequently maintained on an ongoing basis.
• Ability to work effectively in a matrix environment at site influencing ‘Site Training Coordinators’ and ‘Workplace Trainers’
• To have clear oversight of ‘Training Co-ordination’ & ‘Training Delivery’ at site to agreed standardsMonitors effective implementation of GMP, CAPA at site and develop MIS for continious improvement
• Clear understanding of Quality Risk Management and priortise activities based on risk assessment of process equipments, utilities, facilities.
• To ensure a level of ‘governance’ is in place with respect to all vendors associated with site to deliver compliance
• To ensure the QA compliance of ISO 9001,ICH, ISO 22000 and HACCP, BIS, FSSA requirements in and around the manufacturing facility through routine monitoring of compliances
Candidate Profile:
Key Behavioural Competencies Required: Adaptability, Innovation, Initiative, Teamwork, Integrity
• Decision making skills in order to handle the compliances
• Sense of urgency in planning, coordinating of compliance function so as to ensure all regulatory, statutory, corporate, food safety requirements are adhared to
• Interpersonal skill in order to develop healthy relationship between the key customers production and engineering team members
• Communication skills essential to communicate with all stake holders
• Graduate or Post Graduate from Science Background
Additional Information:
Location: Jhagadia
Job ID: 118075BR
Experience: 2-5 year
Industry Type: Pharma / Biotech / Clinical Research
Functional Area: QA
Last Date: 20th nov, 2012
APPLY THROUGH RECRUITERS PORTAL
See All B.Pharm Alerts B.Sc Alerts Ph.D Alerts Mumbai Alerts
See All Other Jobs in our Database
.png)
