Pfizer looking for Quality Compliance Lead | B.Pharm, M.Pharm, M.Sc

Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Post : Quality Compliance Lead

Job Description
Audit & Compliance function development:
• Hire, lead, train the audit & compliance team
• Assists with development and implementation of strategic (long term) and short term goals and objectives for Audit & Compliance function
• Develop and maintain the internal audit program and effectively driving improvement in GMP and quality culture
• Ensure internal quality audit and Regulatory commitments are closed out in accordance with agreed timelines and appropriately address the deficiencies.
Overall supervision of Quality Compliance group and related activities. Ensure compliance to each function of Quality Compliance group, include:
• Audits: Monitor internal, regulatory, third party manufacturing/distribution, material supplier and service provider audits.
• Supplier Quality Assurance: Monitor supplier quality program
• Complaints / FAR / AQRT: Monitor complaints handling at site, initiate FAR as required and compile data required for AQRTs
• APQR/APRR: Monitor compliance to APQR/APRR

Inspection Readiness: Ensure site is ready for inspections.
• Develop Inspection Readiness Plan, execute the plan and report the progress of the plan to management.
• Develop facility inspection schedules and conduct facility inspections to ensure site adherence to written procedures system, cGMP and effectiveness of implemented systems and prepare site for inspection readiness.
• Provide feedback to management on periodic basis in relation to overall facility compliance.
• Track and report metrics for all facility inspection activities.
• Prepare opening meeting presentation, audit strategy, front room and back room strategy and ensure readiness of resources.

Facilitate external/ regulatory inspections and provide support to SQOL
• Mange the back room and co-ordinating with SQA for timely transfer of audit related documents to auditors within stipulated timelines.
• Ensure Site Regulatory Inspection Plan is followed during the inspection.
• Co-ordinate for responses, evaluate applicable corrective and preventive action (CAPA) responses to the inspection findings for adequacy and timeliness.
• Responsible for organizing the proof books / evidence binders for all audit observations.
• Conducting meetings with CFT members for timely closure of audit responses.

Data Integrity Program:
• Develop Data Integrity Plan and deployment of the plan per committed timelines.
• Should perform unannounced data integrity surveillance audits
• Provide feedback to management on periodic basis in relation to overall compliance on data integrity.
• Designing and expanding training and development programs based on the needs of the organization and the individual with respect to Data Integrity.
• Ensure compliance with government regulations in relation to quality and safety (e.g. 21 CFR, EU GMP and PIC/S Code of GMP).
• Review network inspection observations to perform gap assessment and impact on Vizag site; implementation of corrective actions if any.
•Deploy strategies identified by site leadership team towards continuous improvement of the site.
•Identify development needs including clear succession plan for the teams and support their development by coaching and/ or mentoring.
• Enable the team in setting up SMART goals and empower the teams in achieving their objectives.

Quality System Knowledge: Understanding of the US FDA, EU GMP, PIC/S, CDSCO and ISO code of GMP regulatory requirements as it relates to implementation of systems. GMP Knowledge: Trained and experienced in GMP fundamentals of operating a compliant facility. Proven track record of best practice implementation and accomplishments involving quality, manufacturing, engineering, regulatory and warehousing; Knowledge of validation principles and practices related to the following areas: manufacturing process, analytical method, cleaning methods, facility, equipment, instrument, utility system, and IT systems
People Management: Ability to lead a team and delegate/assign work and tasks; Compliance driven approach Problem Solving: Ability to investigate, identify root cause and preventative measures using DMAIC tool and other appropriate tools.
Technical Writing: Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed at different levels of the organization; Knowledge in review of data, trend analysis, and suggesting improvement plans

Additional Information
Qualification : B. Pharm / M. Pharm / M.Sc.
Location : Vizag
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Compliance
End Date : 20th December, 2019