General Manager - Quality Assurance - Pharma

JOB DESCRIPTION:

- Rich knowledge in Extensive Qualifications to design, formulate, implement & review of Quality Standards, Quality Policies, Quality Management Systems and Procedures.

- Strong experience and rich knowledge on cGMP & cGLP regulations and compliance

- Extremely focused in Management's Quality Vision/ Mission/ Objectives, Quality Policies & Business objectives.

- Strong experience in handling of complex formulations with manageable exposures in API/ Bulk drugs.

- Well versed and Rich knowledge on Quality & Regulatory Compliance with adequate experience in the areas of QA, QC & RA

- Strong knowledge on Regulatory requirements of US FDA, EU, MHRA, WHO, TGA and PICs and should have faced several regulatory audits successfully.

- Rich experience in ability to build & maintain a Quality & Compliance Culture at Corporate & all Manufacturing Sites along with Continuous Quality Improvement Projects and Harmonization of Quality Systems & Procedures.

- To prepare and provide guidance on right orientation of quality & operational teams to implement, adhere & deliver in line with quality policies, procedures & QMS within regulatory scope.

- Hands of experience in ability to lead & direct all time readiness for any regulatory inspections through close monitoring of compliance team.

- Should have worked in Challenging environment of Remediation Plans

- Rich Experience in Conducting of Management Review Meetings & Initiatives

- To Set-up of Quality Excellence Objectives, Performance of Quality & Operational Teams, Performance Enhancement Programs

- Should have ability for Identification & Successful Resolution of Overall Quality & Regulatory Concerns with respect to Facility Management, GMP and Quality Management Systems.

- Strong experience and well versed with current guidelines on Vendor Qualification requirements and to ensure compliance against established systems.

- Should have ability to lead and direct Quality Assurance & Quality Control Systems for successful implementation of Systems in adherence to SOPs.

- Strong experience and well versed in various tools of Quality Risk Management with respect to Mfg. Facility, Utilities, Mfg. Equipments, Lab Instruments, Products, Processes, Analytical Methods, QMS Events, Market Complaints, Change Controls etc.

- Rich experience and knowledge on Process Validation & Continuous Process Verification requirements in line with current regulatory guidelines

- Well versed with Cleaning Validation Requirements including Health Based Approaches to execute the validation studies.

- Strong knowledge on Stability Study Managements and to ensure studies are conducted in line with Current Regulatory Expectations.

- Should have thorough knowledge on Training Identification/Requirements and Execution of Scheduled Planner for all the employees.

Desired Candidate Profile:

- A Pharmacy/ Science Graduate/Post Graduate from well-established Pharma Quality Operations background with 18 to 20 years sound experience in reputed Pharma Organizations.

- Ability to work both independently and within a team structure

- Proven ability to lead, influence and motivate colleagues and external partners

- Good knowledge of guidelines from USFDA,MHRA,TGA,MCC and ANVISA

- Strong planning, presentation and interpersonal skills

- Strong work Ethics, Self-motivated, Dedicated & Results orientated

- Significant working knowledge of the pharmaceutical products & processes to provide scientific rationales/ justifications as applicable while handling compliance/ responses to the regulatory agencies and also for all Quality Management systems

- Strong knowledge on handling various Quality Management systems with sound knowledge on investigations and root cause analysis.

- Excellent in written and spoken English

- Multi tasker, strong in systems, process to handle multiple projects/sites

- Can do attitude is a must

- Evaluation of strategic option, costs, time and completion strategy

- Strong internal co-ordination skills

- Ability to handle extreme pressure situations