Quality Management System:
- Responsible for quality oversight of operations at PharmaGend Global Medical Services Pte Ltd facility. Adhere to laid down Quality Management System, its effective implementation and facilitate continuous improvement in all manufacturing area activities, and effective resolution of routine Quality issues.
- Tracking, trending and closing QMS events using TrackWise. Review and Approval of documentation associated with key quality compliance indicators - Deviation, Market Complaints, Product Recalls, CAPAs, Change Controls, Returned Goods and other quality system documents e.g., Product Quality Review, SOP's, Protocols, reports as appropriate and actively participate in investigations.
- Subject matter expert in Qualification and Validation activities related to GMP area, production equipment and key utilities e.g., Purified water system, Compressed air system.
- Review periodically the Quality Performance parameters, review and approve appropriate remedial actions towards compliance and Quality of products supplied. Identify proactively the actions towards continuous improvement and measure performance of Quality through various tools / Quality Indicators.
- Escalate the quality events, trends as appropriate to various management levels in organization for appropriate regulatory actions as applicable and provide close-out actions as deemed necessary / required.
- Ensure timely review and / approval of executed batch records, and final batch release to market. and disposition (Release/Rejection) of in-process and finished product batches as appropriate.
- Implement ongoing process management mechanisms (process mapping, documentation, metrics, monitoring systems and process control techniques).
- Perform periodic review of Quality Performance parameters and approve appropriate remedial actions towards compliance and Quality of products supplied. Identify proactively the actions towards continuous improvement and measure performance of Quality through various tools / Quality Indicators, provide Quality Management Reports.
- Escalate the quality events, trends as appropriate to various management levels in organization for appropriate regulatory actions as applicable and provide close-out actions as deemed necessary / required.
- Conduct internal audits and/or vendor audits as required.
- Ensure the SOPs are in line with the practice and revision thereof if required.
- To ensure that the facility is kept all time ready to handle any regulatory, customer or internal audit.
- Act as a designee to for Head Quality on QMS related matters.
Documentation Compliance:
- Review and approval of master BMR/BPR and issuance of BMR/BPR.
- Control and Management of archived documents.
- Preparation and Review of SOPs/Work instructions and forms related to quality assurance and cross functional departments.
- Review and approval of protocol and reports.
- Ensure effective control of confidential and all technical documents and information networking, timely review and approval of relevant technical documents.
Quality Risk Management:
- Participate in Identification and implement risk approach in validation / qualification area based on overall risk management policy / guidelines to control / mitigate risks.
- Apply risk management tools and techniques.
People Management including Technical Training:
- Assign responsibilities, monitor performance, counsel & provide feedback on team performance, plan & monitor required training and development to ensure a committed & competent team.
- Build strong and positive cross-functional working relationships by working to include them in the improvement activities/training, making sure their needs and requirements are carefully considered.
- Conduct Technical Training (On the Job as well as Classroom) to fellow colleagues, new employees and cross functional team.
Management of interface with Regulators/Customers
- Interact with customers/regulatory bodies in a timely manner to address quality / technical related events to ensure desired outcome and adherence to regulatory commitment and compliance.
- Interpret current Regulatory guidance and implement at site.
- Management technical agreement with ESP and clients.
- Updating GMP Documents as per Regulatory amendments and process requirements.
- Ensure compliance with various regulatory commitments, regulatory requirements and customer requirements as applicable including policies.
Requirements:
- Bachelor's degree and/or Maste's degree in Pharmacy or Chemistry.
- At least 10 to15 years of experience, demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
- More than 8 years experience in pharmaceutical validation, qualification projects.
- In-depth understanding of Manufacturing/Pharma Business
- Strong team leadership skills
- Strong staff coaching and development skills.
- Strong ability to communicate.
- Strong ability to influence in a team environment and collaborate with peers.
- May participate in interactions with various governmental agencies/regulators and external auditors.
- Strong understanding of US FDA regulatory requirements.
- Serves as an active member of the Quality Management Team
- Serves as an expert to identify best practices across the organization, shares and implements as appropriate.
- Interacts with site efforts to ensure consistency in policies and practices.
