Associate Manager

**1.**Laboratory Operations and Quality Management System**:

- Lead and responsible for QC activities such as lab purchase, inventory check.
- Lead and participate in the New Product Introduction for raw material and packaging material.
- Draft SPEC/STP/AWS with the information provided by Tech Transfer for raw material and packaging material
- Draft method validation protocol and report if needed
- Conduct MV/MT as needed
- Release RM/PM according to the SCM plan or production plan
- Write and / or review controlled documentation related to laboratory operations or testing such as SOP's.
- Ensure implementation of SOP for all corresponding activities.
- Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.
- Lead and participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.
- Initiate change control documents.
- Escalate the quality events and trends as appropriate to QC Head.
- Responsible for disposition of samples upon confirmation.
- Initiate CAPEX for equipment purchases.
- Support in budget preparation for QC Laboratory.
- Any other activities as and when assigned by the Superior.

**2.**Instrument Management**
- Maintain QC instrument list, and keep updated
- Responsible for instrument qualification/calibration planning
- Contact third party vendor to perform qualification/calibration
- Track the third party service, confirm the service quality, update to QA/finance if needed
- Whole life cycle management for new instrument, prepare URS/DQ/IOQ/PQ
- Make sure all the qualification/calibration are performed according to the plan
- Update and track repair if needed

**3.**Training/Documentation Compliance**:

- Write and / or review controlled documentation related to laboratory operations or testing such as SOP’s, analytical protocols, analysis reports, forms and validation documents.
- Maintain data integrity in Quality Control activities and ensure appropriate traceability.
- Ensure real time documentation, maintain data integrity and appropriate traceability.
- Maintaining the training record for the whole QC team
- Schedule and track the training for both new team members and current team members

**4.**Audit Management**:

- Ensure compliance with FDA regulations and internal controlled procedures in the Quality Control Laboratory.
- Ensure readiness of QC Laboratory in internal / external laboratory audits.
- Remain abreast of current regulatory, pharmacopeia and cGMP trends.

**5.**People Management including technical training & development / Resource Management**:

- Participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance, and performance of laboratory personnel.
- Support the QC Department training program by imparting training to new staff and complying with Analyst Qualification procedure.
- 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.

**6.**EHS**:
Maintains a safe laboratory environment by complying with recommendations made by EHS.

**EDUCATION**:
Degree / Diploma in science related discipline (e.g. Chemistry, Chemical Engineering, Biomedical Engineering, Biotechnology).

**EXPERIENCE**:
Degree with minimum 4 years of quality control experience in pharmaceutical manufacturing industry.