Assistant Manager / Manager – Quality Control (OPT)

KEY DUTIES AND RESPONSIBILITIES:

• Lead and support QC team for daily QC activities by ensuring timely analysis, documentation, and review of RM/PM/FP/IPC/Stability and Process validation samples as per predefined standards.
• Write and/or review controlled documentation related to laboratory operations or testing such as SOPs, analytical protocols, analysis reports, forms, and validation documents.
• Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.
• Ensure readiness of QC Laboratory in internal/external audits.
• Maintain data integrity in Quality Control activities and ensure appropriate traceability.
• Initiate change control documents.
• Lead and participate in stability program, method validations, technical transfer, method transfer, and validation/qualification activities at the site.
• Participate in New Product Introduction activities.
• Lead and participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.
• Participate in site corrective action/preventive action (CAPA) program. Ensure timely completion of all commitments made under QMS.
• Lead and participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance.
• Lead QC Department training program by imparting training to new staff and comply with Analyst Qualification procedure.
• Escalate quality events and trends as appropriate to QC Head.
• Remain abreast of current regulatory, pharmacopeia, and cGMP trends.
• Serve as subject matter expert on laboratory instrumentation and compliance issues.
• Lead the QC team, evaluate competencies, assign responsibilities, monitor performance, counsel, and provide guidance. Plan & monitor the training and development requirements, motivate staff appropriately to build a committed, motivated & competent team.
• Participate in personnel decisions (interviewing, hiring, performance appraisals, promotions, termination, staff development, improvement plans) regarding subordinate staff.
• Maintain a safe laboratory environment by implementing recommendations made by EHS.
• Initiate CAPEX for equipment purchases.
• Support in budget preparation for QC Laboratory.
• Any other activities as assigned by the Superior.

JOB REQUIREMENTS:

• EDUCATION: Degree in science or related discipline (e.g. Chemistry, Chemical Engineering).
• EXPERIENCE: Minimum 8 years of quality control experience in pharmaceutical manufacturing industry and minimum 2 years of supervisory experience in managing a team.

KNOWLEDGE & SKILLS:

• Possess working knowledge of GMP in the pharmaceutical industry.
• Excellent interpersonal and analytical skills, good verbal, and written communication skills.
• Working knowledge of qualification, calibration, and operation of laboratory equipment such as HPLC, GC, FTIR, and Dissolution equipment.
• Working knowledge of method development, validation, verification of analytical method.
• Familiarity with 21 CFR Part 11 requirements.

TO APPLY:

Candidates are encouraged to apply for this position via email to Phghr@pharmagend.com with the following information in the resume:

• Work experiences and job responsibilities.
• Current and expected salary.
• Reason for leaving.
• Date of availability.
• Education background.

We regret that only shortlisted candidates will be contacted.