Lead - Compliance

☞ Pfizer

View: 101

Update day: 28-05-2024

Location: Visakhapatnam / Vizag Andhra Pradesh

Category: Houseware Science Labor

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Job content

Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve
Pfizer has a scientific, ethical, regulatory and legal obligation to collect and evaluate safety information that may be associated with its products, as well as ensuring data privacy. As a leader in Pfizer’s Quality Assurance group, you will be working with a team that is responsible for ensuring appropriate systems and processes are in place on site and in business units. Your team will ensure that facilities and units will meet and/or exceed the requirements of Pfizer and the regulatory authorities for the quality of the products manufactured on site or by approved vendors. Your managerial skills will help us manage and lead people, technological and financial resources within the division.
As a Senior Manager, you will be setting the objectives for multiple projects in your division. Your managerial and technical skills will help in guiding the team members. You will manage performance of direct and indirect reports and support Operating Unit objectives through goal setting, assessment, coaching and performance evaluation of team members. Your understanding of the external marketplace and customer requirements will facilitate in instituting knowledge sharing practices in your team and outside. You shall be relied on to manage operational activities that support the goals of the division and sets direction for its success.

Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.
How You Will Achieve It
Job Summary
  • Responsibilities for maintaining overall engineering quality compliance at site which includes ensuring compliance towards site procedures, cGMP & Quality systems.
Roles & Responsibilities
  • Support in ensuring engineering equipment/ Instruments / systems is qualified and maintained as per the schedule of calibration, preventive maintenance & periodic re-qualification.
  • Review and approve SAT, IQ, OQ, IOQ, PQ, PRQ & PV protocols
  • Review and approve engineering drawings and layouts
  • Ensure all the engineering personnel performing operation and maintenance of equipment / instrument are trained on relevant procedures
  • Ensure all the engineering personnel performing operation and maintenance of equipment / instrument are trained on relevant procedures
  • Ensure all the standards/ chemicals/ reagents being used in the engineering are in unexpired state.
  • Ensure the activities being carried out in the engineering are in line with the approved procedures
  • Review of equipment breakdown data.
  • Periodic review of calibrations/ performance verifications/ preventive maintenance activities to ensure compliance.
  • Ensuring compliance to user accounts, password management, backup and audit trail per procedures of computerized engineering equipment.
  • Participate in the cross functional department meetings as and when required
  • Support for new/expansion/improvement projects
  • To identify continuous improvement initiatives
  • Ensure implementation of identified initiatives / projects
  • Assists with development and implementation of strategic (long term) and short-term goals and objectives for engineering audit and compliance function.
  • Extending required support during walkthroughs, internal audits & regulatory audits
  • Provide feedback to head engineering on periodic basis in relation to overall engineering system compliance
  • Track and report metrics for engineering inspection system activities.
  • Participate in regulatory inspections
  • Coordinating with SQA for timely transfer of audit related documents to auditors within stipulated timeliness.
  • Conducting meeting with CFT members for timely closure of engineering audit responses.
  • Review of Investigation reports.
  • Review of change controls to analyze the impact of change in product quality, existing systems and procedures.
  • Ensuring on track of the change controls/incidents/CAPAs/effectiveness checks
  • Review and approval of GMP / Quality documents & procedures
  • Supporting investigation team for root cause identification and appropriate CAPA implementation.
  • Drive to Implement the corrective and preventive action to avoid recurrence of the incidents
  • Ensuring on time closure of change controls, corrective actions and preventive actions (CAPAs) and investigations.
  • Supporting in documentation, training, Pfizer Quality Standards (PQS) & other related activities of engineering department
  • Ensure all the engineering procedures like standard operating procedures & testing procedures and other procedures are in place and being followed.
  • Ensure the team to compile the site quality metrics
  • Develop and manage team, facilitate goal setting and review performance periodically.
  • Reviewing performance of team members
  • Interact with the team on regular basis and take the feedback from the team
  • Review pulse/voice survey feedback and take the appropriate actions accordingly
  • Ensuring development of compliance team through individual development plans (IDP)
  • Engage and inspire the team on performance expectations and coach the team to meet those expectations using coaching skill principles.
  • Focus on safety and GMP compliance as operational priorities and as performance measures that should be included in metrics.
  • Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach the team.
  • Effectively monitor the actions of the team. Ensure an active daily presence in the GMP work area to observe the work activity and practices.
  • Review the content of all Leader Led Conversations and, on an annual basis, conduct two ‘Leader Led Conversations’ with the teams aimed at fostering a culture that supports compliance with procedures, including good data management.
  • Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles.
  • Investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
Qualifications
Must-Have
  • Bachelor’s Degree and 12-15 years of experience in pharmaceutical sterile formulations
  • Understanding of the USFDA, EU GMP and ISO Code of GMP regulatory requirements as it relates to implementation of systems
  • Understanding of track wise software is an added advantage
  • Good analytical skills
  • Conversant with quality management systems.
  • Good oral and written communication skills
  • Investigation / root cause identification skills
  • Good Technical Writing skills and problem-solving abilities.
  • Team building and management and coaching skills.
Nice-to-Have
  • Master’s degree and relevant pharmaceutical experience.
  • Proven business management capability.
  • Able to communicate complex information and analyses to a variety of scientific and nonscientific audiences in both verbal and written formats.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
#LI-PFE
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Deadline: 12-07-2024

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