RPG Life Sciences Job Vacancy For Senior Manager QC
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RPG Life Sciences Job Vacancy For Senior Manager QC
Position: Senior Manager QC
Location: Ankleshwar
Job Description:
To lead and manage the strategic and operational performance of the Quality control department, ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to regulatory compliance and achieving commercial success.
Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.
To ensure that all necessary testing is carried out and the associated records evaluated
Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety Policies.
Managing all validation, calibration & qualification activities in QC laboratory, including validation strategy and review of protocols and reports.
Ensuring appropriate investigation of discrepancies, errors, complaints, failures, OOS or adverse events requiring documented review and action.
Implementation, review and usage of Quality control standard operating procedures, Specifications for incoming materials, In-process, Intermediates and Finished products and test method of analysis and analytical protocols.
Work allocation to QC staff and Monitoring daily output. Coordination with other relevant departments in streamlining the departmental activity.
Review and follow up for Accelerated and long term stability studies of finished product and Overall review of stability study program for finished product.
Review of APQR trend data for any OOS, OOT etc. and initiating investigation in coordination with QA department.
Monitoring and follow up for maintenance and regular calibration of all instruments of the Quality control laboratories. Annual maintenance Contract with servicing parties and follows up.
Review of certificate of Analysis of Finished Product.
Equip the laboratories with adequate glassware, chemicals, instruments, reference standard, volumetric standard, biological indicator, cultures, media and personnel for discharge of functions of Quality control.
To ensure that the required initial and continuing training program for Quality Control personnel is carried out and adapted according to need.
QC release of Raw material and packaging materials.
To ensure that appropriate validations, including those of analytical procedures and calibrations of instruments / equipment are done.
Establish or approve procedures for the microbiological testing and microbiological monitoring of F1 and F2 plant material, products and environment including purified water Review of respective trends.
Assurance of Good laboratory practices in the Quality control.
Assessment, qualification and approval of new and existing equipment and Instruments within QC Laboratory.
To participate in self-inspection (internal GMP audits) as an internal auditor.
Review technology transfer document and co-ordinate for analytical method transfer.
Ensuring that the Quality department meets or improves on budget, cost, volume and efficiency targets in line with business objectives. Preparing and justifying the Quality control department’s budget.
Working with all members of staff to maintain and develop the positive progressive culture within QC dept.
Observing and complying with GMP, GLP, GDP & company Health and Safety Policies.
Observing and complying with company Standard Operating Procedures (SOPs)
Managing, motivating, coaching and mentoring direct reports, to higher levels of management capability.
Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement.
Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
Undertaking any other duties, either for this department or any other department within the business, which may be requested by the reporting Manager, for which training and/or an explanation has been provided and understood.
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